Culture Media, Selective And Differential
FDA product code JSI · Class I (low risk) · 21 CFR 866.2360 · Microbiology
285510(k) clearances
0PMA approvals
24recalls
Manufacturers
- Acumedia Manufacturers, Inc. 40
- Otisville Biotech, Inc. 20
- Hardy Media 17
- Isle Media and Sterile Products, Inc. 15
- Lakewood Biochemical Co., Inc. 14
- Anaerobe Systems 12
- Biomerieux Inc 11
- Micro Media Laboratories 11
- American Laboratory Supply, Inc. 10
- Apl Medical Supplies 9
- Remel Co. 9
- Preferred Micro-Media 9
- Granite Diagnostics, Inc. 8
- Interstate Media 8
- Biomedia, Inc. 8
- Central Media 8
- Oxoid U.S.A., Inc. 7
- Bd Becton Dickinson Vacutainer Systems Preanalytic 7
- The Montana Deaconess Medical Center 5
- Biomedica, Inc. 5
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K070691 | BBL Chromagar 0157JSI · Traditional | Becton, Dickinson & CO | 11/20/2007SE |
| K974428 | DipstreakJSI · Traditional | Novamed , Ltd. | 07/30/1998SE |
| K891593 | Listeria Selective Enrichment MediumJSI · Traditional | Oxoid U.S.A., Inc. | 06/09/1989SE |
| K890199 | Dentocult Sm-Strip MutansJSI · Traditional | Orion Corp. | 03/02/1989SE |
| K882182 | Salmonella-Shigella (SS) Agar - Product #P3326JSI · Traditional | Lakewood Biochemical Co., Inc. | 06/06/1988SE |
| K881577 | Modified Selective Streptococcus AgarJSI · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881576 | Selenite BrothJSI · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881575 | Selective Streptococcus AgarJSI · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881572 | XL Agar BaseJSI · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881556 | Trichomonas BrothJSI · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881555 | Tinsdale Agar BaseJSI · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K880125 | Lowenstein-Jensen, SelectiveJSI · Traditional | Hardy Media | 03/31/1988SE |
| K880132 | Dermatophyte Test MediumJSI · Traditional | Hardy Media | 03/30/1988SE |
| K880130 | Ats MediaJSI · Traditional | Hardy Media | 03/30/1988SE |
| K880108 | Corn Meal W/Polysorbate 80JSI · Traditional | Hardy Media | 03/30/1988SE |
| K874344 | Quad Plate (4 Different Media)JSI · Traditional | Lakewood Biochemical Co., Inc. | 11/06/1987SE |
| K873260 | Corynebacteria Isolation MediaJSI · Traditional | Central Media | 11/06/1987SE |
| K873259 | Specialty MediaJSI · Traditional | Central Media | 11/06/1987SE |
| K873258 | Streptococcal Selective Differen. & Enriched MediaJSI · Traditional | Central Media | 11/06/1987SE |
| K873269 | Mycological MediaJSI · Traditional | Central Media | 11/04/1987SE |
| K873265 | Media for Anaerobic/Microaerphilic IsolationJSI · Traditional | Central Media | 10/28/1987SE |
| K873264 | Media for Detection & Verification of ColiformsJSI · Traditional | Central Media | 10/28/1987SE |
| K873262 | Differential MediaJSI · Traditional | Central Media | 10/28/1987SE |
| K873261 | Enteric Isolation MediaJSI · Traditional | Central Media | 10/28/1987SE |
| K873481 | Hektoen Enteric (He) Agar/Xld Agar Biplate #Z3016JSI · Traditional | Lakewood Biochemical Co., Inc. | 10/08/1987SE |
| K873329 | Hektoen Enteric (He) Agar Product #P3330JSI · Traditional | Lakewood Biochemical Co., Inc. | 10/02/1987SE |
| K873228 | Levine Eosin Methylene Blue Agar (Lemb) - #P1507JSI · Traditional | Lakewood Biochemical Co., Inc. | 09/23/1987SE |
| K873227 | Mannitol Salt Agar (Msa) Product #P1706JSI · Traditional | Lakewood Biochemical Co., Inc. | 09/23/1987SE |
| K873226 | Xylose Lysine Deoxycholate Agar - Product #P3601JSI · Traditional | Lakewood Biochemical Co., Inc. | 09/23/1987SE |
| K873225 | Eosin Methylene Blue Agar (Emb) - Product #P1309JSI · Traditional | Lakewood Biochemical Co., Inc. | 09/23/1987SE |
| K873223 | Macconkey Agar - Product #P1606JSI · Traditional | Lakewood Biochemical Co., Inc. | 09/23/1987SE |
| K872301 | Dentocult-Sm Culture-PaddleJSI · Traditional | Orion Corp. | 09/11/1987SE |
| K873055 | Macconkey Agar - Product #P1606JSI · Traditional | Lakewood Biochemical Co., Inc. | 08/24/1987SE |
| K872683 | Iafp Bile Esculin AgarJSI · Traditional | I.A.F. Production, Inc. | 08/11/1987SE |
| K872682 | Iafp S.S. AgarJSI · Traditional | I.A.F. Production, Inc. | 08/11/1987SE |
| K872675 | Iafp Mannitol NaclJSI · Traditional | I.A.F. Production, Inc. | 08/11/1987SE |
| K872672 | Iafp Bile Esculin Azide AgarJSI · Traditional | I.A.F. Production, Inc. | 08/11/1987SE |
| K872669 | Iafp X.L.D. AgarJSI · Traditional | I.A.F. Production, Inc. | 08/11/1987SE |
| K872956 | Sorbitol Macconkey Agar No. 3 CM 813JSI · Traditional | Oxoid U.S.A., Inc. | 08/10/1987SE |
| K872188 | Macconkey W/SorbitolJSI · Traditional | Remel Co. | 06/24/1987SE |
| K872058 | Oricult-N Culture-PaddleJSI · Traditional | Orion Corp. | 06/10/1987SE |
| K870648 | Staphylococcus 110 AgarJSI · Traditional | Hardy Media | 04/14/1987SE |
| K870644 | Brilliant Green AgarJSI · Traditional | Hardy Media | 04/14/1987SE |
| K870643 | Potato Dextrose AgarJSI · Traditional | Hardy Media | 04/14/1987SE |
| K870640 | Cetrimide Selective AgarJSI · Traditional | Hardy Media | 04/14/1987SE |
| K870638 | Bacteroides Bile Esculin AgarJSI · Traditional | Hardy Media | 04/14/1987SE |
| K871094 | Brilliant Green AgarJSI · Traditional | bioMerieux, Inc. | 04/03/1987SE |
| K871088 | Anaerobic LKV Blood AgarJSI · Traditional | bioMerieux, Inc. | 04/03/1987SE |
| K864243 | Macconkey AgarJSI · Traditional | Mds Laboratories, Inc. | 03/31/1987SE |
| K864242 | Hektoen Enteric AgarJSI · Traditional | Mds Laboratories, Inc. | 03/31/1987SE |
| K870502 | Culturia Macconkey-Mug/Modified Tsa SystemsJSI · Traditional | Clinical Convenience Products, Inc. | 02/26/1987SE |
| K870341 | P1012 Be AgarJSI · Traditional | Lakewood Biochemical Co., Inc. | 02/13/1987SE |
| K870340 | Z2017, Bea/Cna 5%SB BiplateJSI · Traditional | Lakewood Biochemical Co., Inc. | 02/13/1987SE |
| K870339 | P4802 BeaJSI · Traditional | Lakewood Biochemical Co., Inc. | 02/13/1987SE |
| K870057 | T1365 (Bird Seed Agar Slant)JSI · Traditional | Lakewood Biochemical Co., Inc. | 02/04/1987SE |
| K864764 | Culturia Macconkey-Mug/Cled SystemsJSI · Traditional | Clinical Convenience Products, Inc. | 12/29/1986SE |
| K864077 | Candida Brom Cresol Green AgarJSI · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 10/31/1986SE |
| K863525 | Dermatophyte Test Medium, Slants and MycoflasksJSI · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 09/19/1986SE |
| K863519 | Cal (Cellobiose-Arginine-Lysine) AgarJSI · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 09/19/1986SE |
| K854672 | Candi-Kit TMJSI · Traditional | Culture Kits, Inc. | 07/11/1986SE |
| K862394 | Biotis Mitis SalivariusJSI · Traditional | Otisville Biotech, Inc. | 07/03/1986SE |
| K862391 | Biotis Desoxycholate AgarJSI · Traditional | Otisville Biotech, Inc. | 07/03/1986SE |
| K862389 | Biotis Acetamide AgarJSI · Traditional | Otisville Biotech, Inc. | 07/03/1986SE |
| K862388 | Biotis TCBS AgarJSI · Traditional | Otisville Biotech, Inc. | 07/03/1986SE |
| K862425 | Macconkey Agar W/Mug, Dri-Form and Pre-FormJSI · Traditional | Gibco Laboratories Life Technologies, Inc. | 07/02/1986SE |
| K860707 | OfpblJSI · Traditional | Remel Co. | 03/11/1986SE |
| K860402 | Biotis Bismuth Sulfite AgarJSI · Traditional | Otisville Biotech, Inc. | 02/24/1986SE |
| K860388 | Biotis KF Streptococcus AgarJSI · Traditional | Otisville Biotech, Inc. | 02/24/1986SE |
| K860386 | Biotis SF BrothJSI · Traditional | Otisville Biotech, Inc. | 02/24/1986SE |
| K860385 | Biotis Mac-MugJSI · Traditional | Otisville Biotech, Inc. | 02/24/1986SE |
| K855205 | Mycotrim TM VL Triphasic Culture SystemJSI · Traditional | Hana Biologics, Inc. | 02/05/1986SE |
| K855110 | Dri-Form Ureaplasma Differential Basal Agar MED.A8JSI · Traditional | Gibco Laboratories Life Technologies, Inc. | 01/07/1986SE |
| K854452 | Mannitol Salt AgarJSI · Traditional | R. Kent Richards, Inc. | 11/18/1985SE |
| K854450 | Bile Esculin Azide AgarJSI · Traditional | R. Kent Richards, Inc. | 11/18/1985SE |
| K854449 | Hektoen Enteric AgarJSI · Traditional | R. Kent Richards, Inc. | 11/18/1985SE |
| K853691 | Tergitol 7 AgarJSI · Traditional | Micro Media Laboratories | 09/17/1985SE |
| K853617 | Apl Simmons Citrate AgarJSI · Traditional | Apl Medical Supplies | 09/16/1985SE |
| K853611 | Apl Xylose Lysine Deoxycholate AgarJSI · Traditional | Apl Medical Supplies | 09/12/1985SE |
| K853488 | Staph KitJSI · Traditional | Culture Kits, Inc. | 08/28/1985SE |
| K853235 | Apl Hektoen Enteric AgarJSI · Traditional | Apl Medical Supplies | 08/19/1985SE |
| K853234 | Apl Macconkey AgarJSI · Traditional | Apl Medical Supplies | 08/19/1985SE |
| K853232 | Apl Mannitol Salt AgarJSI · Traditional | Apl Medical Supplies | 08/19/1985SE |
| K853229 | Apl 6.5% Sodium Chloride BrothJSI · Traditional | Apl Medical Supplies | 08/19/1985SE |
| K853228 | Apl Salmonella-Shigella AgarJSI · Traditional | Apl Medical Supplies | 08/19/1985SE |
| K853226 | Apl Biggy Agar(Nickerson)JSI · Traditional | Apl Medical Supplies | 08/19/1985SE |
| K853225 | Apl Levine Emb AgarJSI · Traditional | Apl Medical Supplies | 08/19/1985SE |
| K852789 | Aeromonas Agar(Xdca)JSI · Traditional | Gibco Laboratories Life Technologies, Inc. | 07/19/1985SE |
| K852480 | Derm-KitJSI · Traditional | Culture Kits, Inc. | 07/09/1985SE |
| K851594 | SF BrothJSI · Traditional | Preferred Micro-Media | 05/14/1985SE |
| K851603 | Xylose Lysine Desoxycholate AgarJSI · Traditional | Preferred Micro-Media | 05/08/1985SE |
| K851578 | Bile Esculin AgarJSI · Traditional | Preferred Micro-Media | 05/08/1985SE |
| K851577 | Bile Esculin Azide AgarJSI · Traditional | Preferred Micro-Media | 05/08/1985SE |
| K851583 | Hektoen Enteric AgarJSI · Traditional | Preferred Micro-Media | 05/02/1985SE |
| K851581 | Dermatophyte Test MediumJSI · Traditional | Preferred Micro-Media | 05/02/1985SE |
| K851586 | Macconkey AgarJSI · Traditional | Preferred Micro-Media | 04/30/1985SE |
| K851585 | Mannitol Salt AgarJSI · Traditional | Preferred Micro-Media | 04/30/1985SE |
| K851584 | Levine Emb AgarJSI · Traditional | Preferred Micro-Media | 04/30/1985SE |
| K850723 | Sabouraud's Dextrose Agar, Bordet Gengou Agar, MycJSI · Traditional | Rapid City Regional Hospital, Inc. | 03/22/1985SE |
| K850720 | Eosin Methylene Blue Agar, SS Agar, XLD Agar 6.5%JSI · Traditional | Rapid City Regional Hospital, Inc. | 03/22/1985SE |
| K850736 | Selective Culture MediumJSI · Traditional | Roseville Medical Laboratoriesu | 03/20/1985SE |
| K850565 | Biotis Chocolate TelluriteJSI · Traditional | Otisville Biotech, Inc. | 03/13/1985SE |
| K850552 | Bile Esculin Agar W/Azide, Bea W/AzideJSI · Traditional | Hardy Media | 03/11/1985SE |
| K844933 | Bile Esculin AgarJSI · Traditional | American Laboratory Supply, Inc. | 02/27/1985SE |
| K844930 | Brillant Green AgarJSI · Traditional | American Laboratory Supply, Inc. | 02/27/1985SE |
| K844934 | Azide Agar W/5% Sheep BloodJSI · Traditional | American Laboratory Supply, Inc. | 02/25/1985SE |
| K844515 | Violet Red Bile AgarJSI · Traditional | bioMerieux, Inc. | 01/07/1985SE |
| K844535 | Yersinia Selective AgarJSI · Traditional | bioMerieux, Inc. | 01/05/1985SE |
| K844195 | Biotis Anaerobic Kbe AgarJSI · Traditional | Otisville Biotech, Inc. | 11/27/1984SE |
| K834423 | S S Agar PlateJSI · Traditional | Otisville Biotech, Inc. | 10/23/1984SE |
| K834420 | Mannitol-Salt Agar Usp PlateJSI · Traditional | Otisville Biotech, Inc. | 10/23/1984SE |
| K843767 | Biotis Urea AgarJSI · Traditional | Otisville Biotech, Inc. | 10/10/1984SE |
| K843763 | Biotis Emb Agar Holt-HarrisJSI · Traditional | Otisville Biotech, Inc. | 10/10/1984SE |
| K843762 | Biotis Emb-Levine AgarJSI · Traditional | Otisville Biotech, Inc. | 10/10/1984SE |
| K843761 | Biotis Biggy Agar & Biggy SlantJSI · Traditional | Otisville Biotech, Inc. | 10/10/1984SE |
| K843492 | Neomycin Blood AgarJSI · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 10/02/1984SE |
| K843194 | V Agar Selective DeepsJSI · Traditional | Remel Co. | 09/14/1984SE |
| K843193 | Strep Selective IIJSI · Traditional | Remel Co. | 09/14/1984SE |
| K843066 | Biotis Cin Agar PlatesJSI · Traditional | Otisville Biotech, Inc. | 08/20/1984SE |
| K842101 | Coba AgarJSI · Traditional | Acumedia Manufacturers, Inc. | 06/07/1984SE |
| K842100 | Macconkey Agar, PlusJSI · Traditional | Acumedia Manufacturers, Inc. | 06/07/1984SE |
| K841753 | Macconkey AgarJSI · Traditional | The Montana Deaconess Medical Center | 06/07/1984SE |
| K841752 | Xylose-Lysine Desoxycholate AgarJSI · Traditional | The Montana Deaconess Medical Center | 06/07/1984SE |
| K841747 | Mannitol Salt AgarJSI · Traditional | The Montana Deaconess Medical Center | 06/07/1984SE |
| K841844 | Differential Culture Medium-Biggy AgarJSI · Traditional | Microline Scientific | 05/31/1984SE |
| K841842 | Differential Culture Med. Macconkey AgarJSI · Traditional | Microline Scientific | 05/31/1984SE |
| K841751 | Levine Eosin Methylene Blue AgarJSI · Traditional | The Montana Deaconess Medical Center | 05/31/1984SE |
| K841841 | Differential Culture Med. Mannitol SaltJSI · Traditional | Microline Scientific | 05/25/1984SE |
| K841745 | Hektoen Enteric AgarJSI · Traditional | The Montana Deaconess Medical Center | 05/11/1984SE |
| K841304 | Haemophilus Id Quad-PlateJSI · Traditional | Gibco Laboratories Life Technologies, Inc. | 04/17/1984SE |
| K841209 | Selective and DifferentialJSI · Traditional | Smith River Biologicals | 04/17/1984SE |
| K841207 | Non-Selective & Non-DifferentialJSI · Traditional | Smith River Biologicals | 04/17/1984SE |
| K840338 | Haemophilus I.D. II TriplateJSI · Traditional | Remel Co. | 04/17/1984SE |
| K841218 | Cycloserine-Cefoxitin Fructose AgarJSI · Traditional | Anaerobe Systems | 04/05/1984SE |
| K841142 | Levine Eosin Methylene Blue AgarJSI · Traditional | Anaerobe Systems | 04/05/1984SE |
| K841222 | Bacteroides Bile Esculin GarJSI · Traditional | Anaerobe Systems | 04/04/1984SE |
| K841141 | Macconkey AgarJSI · Traditional | Anaerobe Systems | 03/26/1984SE |
| K841134 | Mannitol Salt AgarJSI · Traditional | Anaerobe Systems | 03/26/1984SE |
| K841132 | Eile-Esculin Azide AgarJSI · Traditional | Anaerobe Systems | 03/23/1984SE |
| K841131 | Xylose Lysine Desoxycholate AgarJSI · Traditional | Anaerobe Systems | 03/23/1984SE |
| K841129 | Hektoen Enteric AgarJSI · Traditional | Anaerobe Systems | 03/23/1984SE |
| K840889 | Clostridium Difficile Agar Deep &JSI · Traditional | Remel Co. | 03/23/1984SE |
| K840615 | Yersinia SupplementJSI · Traditional | Remel Co. | 03/09/1984SE |
| K840160 | B-Strep-Tect-IiJSI · Traditional | Uti-Tect, Inc. | 03/02/1984SE |
| K840294 | Group a Selective Agar W/5% Sheep BloodJSI · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 02/17/1984SE |
| K840190 | Macconkey Agar W/Tween 80 & AmpicilJSI · Traditional | Remel Co. | 02/17/1984SE |
| K834320 | TCBSJSI · Traditional | Hardy Media | 01/13/1984SE |
| K834019 | Biggy Agar Nickerson MediumJSI · Traditional | Micro Media Laboratories | 12/22/1983SE |
| K833508 | Prepared Macconkey AgarJSI · Traditional | Lavco Laboratory, Inc. | 11/07/1983SE |
| K833301 | Feeley-Gorman AgarJSI · Traditional | Acumedia Manufacturers, Inc. | 10/28/1983SE |
| K833254 | Streptococcus Id Triplate SystemJSI · Traditional | Granite Diagnostics, Inc. | 10/28/1983SE |
| K833219 | Staphylococcus Agar 10JSI · Traditional | Acumedia Manufacturers, Inc. | 10/27/1983SE |
| K833212 | Mac Conkey Agar Without Crystal VioletJSI · Traditional | Acumedia Manufacturers, Inc. | 10/27/1983SE |
| K833205 | Yersinia Selective AgarJSI · Traditional | Acumedia Manufacturers, Inc. | 10/27/1983SE |
| K833204 | Deoxycholate Citrate AgarJSI · Traditional | Acumedia Manufacturers, Inc. | 10/27/1983SE |
| K833203 | Deoxycholate Lactose AgarJSI · Traditional | Acumedia Manufacturers, Inc. | 10/27/1983SE |
| K832535 | Hektoen Enteric Agar PlateJSI · Traditional | Otisville Biotech, Inc. | 10/04/1983SE |
| K832524 | Baird Parker Agar PlateJSI · Traditional | Otisville Biotech, Inc. | 10/04/1983SE |
| K832523 | Tryptose Sulfite Cycloserine Agar PlateJSI · Traditional | Otisville Biotech, Inc. | 10/04/1983SE |
| K832955 | Bacteroides Bile Esculin AgarJSI · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 09/29/1983SE |
| K832954 | V AgarJSI · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 09/29/1983SE |
| K832863 | Strep Id QuadJSI · Traditional | Troy Biologicals, Inc. | 09/26/1983SE |
| K832618 | Blue AgarJSI · Traditional | Carroll Biological Corp. | 09/12/1983SE |
| K832617 | Xylose Lysine DeoxycholateJSI · Traditional | Carroll Biological Corp. | 09/12/1983SE |
| K832572 | Bile Esculin AgarJSI · Traditional | Acumedia Manufacturers, Inc. | 09/12/1983SE |
| K832571 | Bile Esculin Azide AgarJSI · Traditional | Acumedia Manufacturers, Inc. | 09/12/1983SE |
| K832365 | TCBS AgarJSI · Traditional | Granite Diagnostics, Inc. | 09/01/1983SE |
| K830251 | Campy Blood Agar PlateJSI · Traditional | Granite Diagnostics, Inc. | 02/28/1983SE |
| K830082 | Biggy AgarJSI · Traditional | bioMerieux, Inc. | 02/10/1983SE |
| K830065 | Salmonella-Shigella AgarJSI · Traditional | bioMerieux, Inc. | 02/10/1983SE |
| K830079 | Bismuth Sulfite AgarJSI · Traditional | bioMerieux, Inc. | 02/09/1983SE |
| K830072 | Hektoen Enteric AgarJSI · Traditional | bioMerieux, Inc. | 02/09/1983SE |
| K830071 | Macconkey AgarJSI · Traditional | bioMerieux, Inc. | 02/09/1983SE |
| K830070 | Mannitol Salt AgarJSI · Traditional | bioMerieux, Inc. | 02/09/1983SE |
| K830064 | XLD AgarJSI · Traditional | bioMerieux, Inc. | 02/09/1983SE |
| K823310 | Streptococcus Selective AgarJSI · Traditional | Troy Biologicals, Inc. | 12/15/1982SE |
| K823307 | Campylobacter Selective AgarJSI · Traditional | Troy Biologicals, Inc. | 12/15/1982SE |
| K823306 | Hemophilus Quad 10 PlateJSI · Traditional | Troy Biologicals, Inc. | 12/15/1982SE |
| K823122 | Laked Blood Agar W/Paromomycin & VancomJSI · Traditional | Granite Diagnostics, Inc. | 12/03/1982SE |
| K822737 | Mycotrium-RsJSI · Traditional | Hana Biologics, Inc. | 12/03/1982SE |
| K822736 | Mycotrium-GuJSI · Traditional | Hana Biologics, Inc. | 12/03/1982SE |
| K822997 | Strep Selective AgarJSI · Traditional | Granite Diagnostics, Inc. | 11/17/1982SE |
| K822855 | Yersinia Isolation MediumJSI · Traditional | Granite Diagnostics, Inc. | 11/05/1982SE |
| K821608 | Cna/Vaginalis AgarJSI · Traditional | Hardy Media | 07/06/1982SE |
| K821605 | Xylose Lysine Deoxycholate AgarJSI · Traditional | Hardy Media | 07/06/1982SE |
| K821775 | Tergitol 7 Agar with TTCJSI · Traditional | Granite Diagnostics, Inc. | 07/02/1982SE |
| K821300 | #2010 Camphylobacter AgarJSI · Traditional | Biomedia, Inc. | 06/02/1982SE |
| K821431 | XLD AgarJSI · Traditional | Interstate Media | 06/01/1982SE |
| K821427 | Mannitol Salt AgarJSI · Traditional | Interstate Media | 06/01/1982SE |
| K821426 | Staphylococcus Medium 1100JSI · Traditional | Interstate Media | 06/01/1982SE |
| K821423 | Macconkey AgarJSI · Traditional | Interstate Media | 06/01/1982SE |
| K821422 | SS AgarJSI · Traditional | Interstate Media | 06/01/1982SE |
| K821421 | Hektoen Enteric AgarJSI · Traditional | Interstate Media | 06/01/1982SE |
| K821420 | Emb AgarJSI · Traditional | Interstate Media | 06/01/1982SE |
| K821419 | Emb AgarJSI · Traditional | Interstate Media | 06/01/1982SE |
| K821301 | #50002 Quad Diagnostic SystemJSI · Traditional | Biomedia, Inc. | 06/01/1982SE |
| K821108 | Bi Plate-Xld/Hektoen #30012JSI · Traditional | Biomedia, Inc. | 05/13/1982SE |
| K820844 | Culture Media, Selective & DifferentialJSI · Traditional | Blue Ridge Media Co. | 04/16/1982SE |
| K820802 | #2009 Biggy AgarJSI · Traditional | Biomedica, Inc. | 04/08/1982SE |
| K820801 | #2007 XLDJSI · Traditional | Biomedica, Inc. | 04/08/1982SE |
| K820800 | #2006 Salmonella Shigella AgarJSI · Traditional | Biomedica, Inc. | 04/08/1982SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2226-2025 Class II | Blood/MacConkey Biplate 100/PK, Product Number R02049The products may contain surface and subsurface contamination of Listeria monocytogenes. | Remel, Inc | 07/11/2025Open, Classified |
| Z-2225-2025 Class II | Blood/EMB, Levine 100/PK, Product Number R02041The products may contain surface and subsurface contamination of Listeria monocytogenes. | Remel, Inc | 07/11/2025Open, Classified |
| Z-2224-2025 Class II | Strep Selective II Agar, Product Number R01859The products may contain surface and subsurface contamination of Listeria monocytogenes. | Remel, Inc | 07/11/2025Open, Classified |
| Z-1829-2025 Class II | BD MICROBIOLOGY MAC CONKEY II AGAR (100/CT) 21270 MEDIA.transit delays of certain cold chain products due to severe thunderstorms which may caused the products to… | Mckesson Medical-Surgical Inc. Corporate… | 04/24/2025Open, Classified |
| Z-1201-2025 Class II | remel BLOOD AGAR EMB AGAR BIPLATE, REF R02041, QTY 100, for invitro diagnostic useProduct may contain surface and subsurface contamination of Listeria monocytogenes which is typically… | Remel, Inc | 02/13/2025Open, Classified |
| Z-1200-2025 Class II | remel BLOOD AGAR MacCONKEY AGAR BIPLATE, REF R02049, QTY 100, for invitro diagnostic useProduct may contain surface and subsurface contamination of Listeria monocytogenes which is typically… | Remel, Inc | 02/13/2025Open, Classified |
| Z-0804-2023 Class II | PPM CLINICAL CRAPONNE CHROMID C.DIFFICILE 20 PLT, CATALOG 43871As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Biomerieux Inc | 11/09/2022Open, Classified |
| Z-0801-2023 Class II | PPM CLINICAL CRAPONNE CLINICAL CHROMID CANDIDA 20 PLATES, CATALOG 43631As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Biomerieux Inc | 11/09/2022Open, Classified |
| Z-0769-2021 Class II | Remel Blood Agar/MacConkey Agar Bi-Plate, REF: R02049The blood agar side of the bi-plate may not grow some patient isolates or QC organisms as intended. | Remel Inc | 12/10/2020Terminated |
| Z-0283-2019 Class III | Palcam Agar Base, Acumedia, PN 7669, Product Usage - Dehydrated culture media used with…Expiration date on the label is incorrect. Correct expiration date was November 30, 2020 and label on… | Acumedia Manufacturers, Inc. | 08/02/2018Terminated |
| Z-2221-2017 Class III | Urea Base Agar, Acumedia PN 7226 Urea Agar Base is used with agar for the…Storage temperature listed on the label was incorrect. Label stated 2-30C. Actual storage temperature is 2-8C. | Acumedia Manufacturers, Inc. | 09/25/2016Terminated |
| Z-1559-2016 Class II | Trypticase TM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar Cat. Number…Trypticase TM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar is contaminated with Listeria… | Becton Dickinson & Co. | 03/28/2016Terminated |
| Z-1314-2016 Class II | NEL- GBS Medium (Broth 3 ml Fill 13 x 100 mm Screw Cap Tube Catalog No.: T8000; For the…Product marketed without a 510 (k) | Northeast Laboratory Services, Inc. | 12/21/2015Terminated |
| Z-1313-2016 Class II | NEL GBS Medium 20 ml in 100x15mm plate (Standard Petri Dish) Catalog No.: P8000; For the…Product marketed without a 510 (k) | Northeast Laboratory Services, Inc. | 12/21/2015Terminated |
| Z-2584-2017 Class II | Palcam Supplement Acumedia PN 7987 Product Usage: PALCAM Supplement is used with PALCAM…Contamination of product with possible Bacillus spp | Acumedia Manufacturers, Inc. | 11/30/2015Terminated |
| Z-1444-2015 Class II | Hardy Diagnostics cat no. G327 HardyCHROM SS Agar (HardyCHROM Salmonella Shigella) Cat…The firm is recalling HardyCHROM SS, Cat. no. G327 Lot no. 15037 due to a report of possible lack of color… | Hardy Diagnostics | 03/04/2015Terminated |
| Z-0974-2015 Class II | TrypticaseTM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar Trypticase Soy…A low level of surface and subsurface contamination of Listeria monocytogenes on 9 lots of non-sterile… | Becton Dickinson & Co. | 06/06/2014Terminated |
| Z-1805-2013 Class II | BBL Campylobacter CSM Agar (Charcoal-Based Selective Medium), Catalog # 299614, packaged…Microbiological identification media may exhibit reduced levels of Vancomycin. | Becton Dickinson & Co. | 06/06/2013Terminated |
| Z-1804-2013 Class II | BD BBL BCYE Selective Agar with PAV, Catalog # 297880, packaged in cartons of 10 plates…Microbiological identification media may exhibit reduced levels of Vancomycin. | Becton Dickinson & Co. | 06/06/2013Terminated |
| Z-1803-2013 Class II | BBL Brucella Laked Blood Agar with Kanamycin and Vancomycin (KV), Catalog # 297840…Microbiological identification media may exhibit reduced levels of Vancomycin. | Becton Dickinson & Co. | 06/06/2013Terminated |
| Z-1802-2013 Class II | BD BBL BBE // CDC Anaerobe Laked Sheep Blood Agar with KV, packaged in cartons of 100…Microbiological identification media may exhibit reduced levels of Vancomycin. | Becton Dickinson & Co. | 06/06/2013Terminated |
| Z-1333-2013 Class II | BBL(tm) Trypticase (tm) Soy Agar with 5% Sheep Blood and MacConkey II-I Plate. Used for…Microbiological media may be contaminated with bacteria. | Becton Dickinson & Co. | 03/11/2013Terminated |
| Z-1787-2010 | Difco (TM) Decarboxylase Base Moeller, packaged in 500 gm bottles, labeled in part…Diagnostic test reagents may not meet quality control specifications. | Becton Dickinson & Co. | 12/09/2009Terminated |
| Z-0621-2007 | Remel MacConkey Agar w/Sorbitol, growth medium, Catalog R01556, packaged 10/box. The…False negative results for sorbitol fermenting bacteria such as E. Coli 0157. | Remel, Inc. | 02/21/2007Terminated |