Culture Media, Enriched
FDA product code KZI · Class I (low risk) · 21 CFR 866.2330 · Microbiology
51510(k) clearances
0PMA approvals
1recalls
Manufacturers
- Hardy Media 9
- Lakewood Biochemical Co., Inc. 6
- Otisville Biotech, Inc. 4
- Biomerieux Inc 3
- I.A.F. Production, Inc. 3
- Bd Becton Dickinson Vacutainer Systems Preanalytic 3
- Microline Scientific 3
- Preferred Micro-Media 2
- Apl Medical Supplies 2
- The Montana Deaconess Medical Center 2
- R. Kent Richards, Inc. 2
- Gibco Laboratories Life Technologies, Inc. 2
- Central Media 2
- Otisville Biopharm, Inc. 2
- Roseville Medical Laboratoriesu 1
- Rapid City Regional Hospital, Inc. 1
- Mds Laboratories, Inc. 1
- American Laboratory Supply, Inc. 1
- Remel Co. 1
- Oxoid U.S.A., Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K884208 | Listeria Selective Medium (Oxford Formulation)KZI · Traditional | Oxoid U.S.A., Inc. | 10/25/1988SE |
| K881995 | Diamond's Medium ModifiedKZI · Traditional | Remel Co. | 06/02/1988SE |
| K880134 | Middlebrook 7H11 AgarKZI · Traditional | Hardy Media | 03/31/1988SE |
| K880131 | Lowenstein-Jensen, GruftKZI · Traditional | Hardy Media | 03/31/1988SE |
| K880122 | Middlebrook 7H9 BrothKZI · Traditional | Hardy Media | 03/31/1988SE |
| K880138 | Wallenstein Medium SlantKZI · Traditional | Hardy Media | 03/30/1988SE |
| K880109 | Cystine Tryptic Medium BaseKZI · Traditional | Hardy Media | 03/30/1988SE |
| K880127 | Potato Dextrose AgarKZI · Traditional | Hardy Media | 03/07/1988SE |
| K874179 | Biotis (TM) Sabhi (Double Pour)KZI · Traditional | Otisville Biopharm, Inc. | 01/28/1988SE |
| K874177 | Biotis (TM) BcyeKZI · Traditional | Otisville Biopharm, Inc. | 12/04/1987SE |
| K873267 | ECG Based MediaKZI · Traditional | Central Media | 11/04/1987SE |
| K873266 | Middlebrook Based MediaKZI · Traditional | Central Media | 10/28/1987SE |
| K873952 | Micro Culture Media P3141, P3136, P3148, P3748KZI · Traditional | Lakewood Biochemical Co., Inc. | 10/23/1987SE |
| K873321 | Sabour Dextrose/Bhi Sd/Bhi Agar SLT Tube #T4300KZI · Traditional | Lakewood Biochemical Co., Inc. | 09/29/1987SE |
| K873320 | Sabouraud Dextr/Bhi Sd/Bhi Agar SLT W/6% Sheep BLDKZI · Traditional | Lakewood Biochemical Co., Inc. | 09/29/1987SE |
| K873061 | Tryptic Soy Agar W/5% Sheep Blood - #T1405KZI · Traditional | Lakewood Biochemical Co., Inc. | 08/24/1987SE |
| K873060 | Tryptic Soy Agar W/5% Sheep Blood - Product P1002KZI · Traditional | Lakewood Biochemical Co., Inc. | 08/24/1987SE |
| K873058 | Tryptic Soy Agar (Tsa) W/5% Horse Blood #P2810KZI · Traditional | Lakewood Biochemical Co., Inc. | 08/24/1987SE |
| K872685 | Iafp Lowenstein Jensen SlantKZI · Traditional | I.A.F. Production, Inc. | 08/11/1987SE |
| K872678 | Iafp Thioglycollate W/O Indicator W/Hemin&Vita. K1KZI · Traditional | I.A.F. Production, Inc. | 08/07/1987SE |
| K872671 | Iafp T.S.A. W/5% Sheep BloodKZI · Traditional | I.A.F. Production, Inc. | 08/07/1987SE |
| K872193 | Fletcher's Medium & Fletcher's Medium W/5-FUKZI · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 06/22/1987SE |
| K870646 | Middlebrook 7H10 AgarKZI · Traditional | Hardy Media | 04/14/1987SE |
| K870642 | Cooked Meat Medium with IronKZI · Traditional | Hardy Media | 04/14/1987SE |
| K870634 | Tetrathionate BrothKZI · Traditional | Hardy Media | 04/14/1987SE |
| K871092 | Horse Blood Agar, EnrichedKZI · Traditional | bioMerieux, Inc. | 04/03/1987SE |
| K864238 | Chocolate AgarKZI · Traditional | Mds Laboratories, Inc. | 03/31/1987SE |
| K864014 | Lombard Dowell Agar BaseKZI · Traditional | Gibco Laboratories Life Technologies, Inc. | 10/29/1986SE |
| K862761 | Vacutainer Brand Agar SlantKZI · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 08/04/1986SE |
| K862390 | Biotis Bordet Gengou AgarKZI · Traditional | Otisville Biotech, Inc. | 07/03/1986SE |
| K860410 | Biotis Cooked MeatKZI · Traditional | Otisville Biotech, Inc. | 02/24/1986SE |
| K854454 | Tryptic Soy Blood AgarKZI · Traditional | R. Kent Richards, Inc. | 11/18/1985SE |
| K854228 | Columbia 5% Blood AgarKZI · Traditional | R. Kent Richards, Inc. | 10/31/1985SE |
| K854064 | Bcye (Buffered Charcoal Yeast Extract) AgarKZI · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 10/23/1985SE |
| K853236 | Apl Tsa with 5% Sheep BloodKZI · Traditional | Apl Medical Supplies | 08/19/1985SE |
| K853233 | Apl Chocolate AgarKZI · Traditional | Apl Medical Supplies | 08/19/1985SE |
| K851600 | Tryptic Soy Agar W/5% Sheep BloodKZI · Traditional | Preferred Micro-Media | 05/08/1985SE |
| K851588 | Chocolate AgarKZI · Traditional | Preferred Micro-Media | 04/30/1985SE |
| K850724 | Culture Media Nonselective & NondifferentialKZI · Traditional | Rapid City Regional Hospital, Inc. | 03/25/1985SE |
| K850735 | Enriched Culture MediumKZI · Traditional | Roseville Medical Laboratoriesu | 03/16/1985SE |
| K843065 | Biotis CDC Modified Mcclung-Toabe EggKZI · Traditional | Otisville Biotech, Inc. | 08/20/1984SE |
| K841749 | Chocolate AgarKZI · Traditional | The Montana Deaconess Medical Center | 05/31/1984SE |
| K841748 | Sheep Blood AgarKZI · Traditional | The Montana Deaconess Medical Center | 05/31/1984SE |
| K841586 | Chocolate AgarKZI · Traditional | Microline Scientific | 05/31/1984SE |
| K841838 | Enriched Culture Med. Tryptic Soy AgarKZI · Traditional | Microline Scientific | 05/21/1984SE |
| K841837 | Enriched Culture Med. Fluid THIOGLYC0KZI · Traditional | Microline Scientific | 05/21/1984SE |
| K832533 | Selenite Cystine BrothKZI · Traditional | Otisville Biotech, Inc. | 10/04/1983SE |
| K830383 | Fildes Enrichment SolutonKZI · Traditional | Gibco Laboratories Life Technologies, Inc. | 03/08/1983SE |
| K830078 | Blood Agar(Tsa W/5% Sheep Blood)KZI · Traditional | bioMerieux, Inc. | 02/09/1983SE |
| K830074 | Chocolate Agar, EnrichedKZI · Traditional | bioMerieux, Inc. | 02/09/1983SE |
| K820563 | Thioglycollate EnrichedKZI · Traditional | American Laboratory Supply, Inc. | 03/16/1982SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0643-2010 | BBL (TM) Brain Heart Infusion, Catalog number 221778, package of 100 tubes, 0.5 mL…In vitro diagnostic test reagent may contain residual material that inhibits the growth of gram… | Becton Dickinson & Co. | 02/19/2009Terminated |