Difco Laboratories, Inc.
Medical device manufacturer in Detroit, MI.
121510(k) clearances
0PMA approvals
0recalls
Device types
- JTN Susceptibility Test Discs, Antimicrobial 41
- JTO Discs, Strips And Reagents, Microorganism… 34
- MDB System, Blood Culturing 3
- KIR Cells, Animal And Human, Cultured 3
- JTW System, Transport, Aerobic 3
- JSF Culture Media, Single Biochemical Test 3
- GTZ Antisera, All Groups, Streptococcus Spp. 3
- LED Stains, Chemical Solution 2
- LJP Antiserum, Fluorescent, Chlamydia Trachomatis 2
- DHR System, Test, Rheumatoid Factor 1
- JWX Kit, Screening, Staphylococcus Aureus 1
- KFC Methylene Blue, Tissue Stain 1
- DCN System, Test, C-Reactive Protein 1
- GQL Antisera, Fluorescent, Herpesvirus Hominis… 1
- JTT Susceptibility Test Powders, Antimicrobial 1
- JXA Kit, Screening, Urine 1
- JSM Culture Media, Non-Propagating Transport 1
- LKT Respiratory Syncytial Virus, Antigen… 1
- JTS Stains, Microbiologic 1
- LTS Test Reagents, Neisseria Gonorrhoeae… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K971211 | Dispens-O-Disc SparfloxacinJTN · Traditional | 04/14/1997SE |
| K971120 | Dispens-O-Disc (TM) LevofloxacinJTN · Traditional | 04/14/1997SE |
| K963508 | Dispens-O-Disc MeropenemJTN · Traditional | 09/26/1996SE |
| K961148 | Cefepime Dispans-O-Disc (Cefeplime - 30MCG)JTW · Traditional | 04/26/1996SE |
| K954783 | Dryslide CartarrhalisJTO · Traditional | 02/06/1996SE |
| K954784 | Dryside NeisseriaLTS · Traditional | 01/30/1996SE |
| K953129 | Esp Culture System - MycoMDB · Traditional | 12/26/1995SE |
| K950706 | Dryslide CoagulaseJTL · Traditional | 05/16/1995SE |
| K944275 | Dispens-O-Disc Piperacillin 100 Mcg./Tazobactam 10 Mcg.JTN · Traditional | 12/19/1994SE |
| K941016 | Dispens-O-Disc(Tm) NitrocefinJTO · Traditional | 06/30/1994SE |
| K934894 | Cultureswab Transport SystemJTW · Traditional | 02/22/1994SE |
| K930702 | Dryslide CefinJTN · Traditional | 12/22/1993SE |
| K930946 | Dispens-O-Disc Cefpodoxime 10 Mcg.JTN · Traditional | 04/27/1993SE |
| K930911 | Dispens-O-Disc Clarithromycin 15 Mg.JTN · Traditional | 04/27/1993SE |
| K925747 | Dryslide(Tm) IndoleJTO · Traditional | 01/15/1993SE |
| K925693 | Ez ViewMDB · Traditional | 01/15/1993SE |
| K922792 | ZithromaxJNT · Traditional | 07/30/1992SE |
| K922794 | EnoxacinJTN · Traditional | 07/28/1992SE |
| K922793 | CefzilJTN · Traditional | 07/28/1992SE |
| K922791 | Loracarbef 30MCG DiskJTN · Traditional | 07/28/1992SE |
| K921637 | Esp Blood Culture SystemMDB · Traditional | 07/14/1992SE |
| K921583 | Dryslide(Tm), PyrJTO · Traditional | 06/19/1992SE |
| K921282 | MaxaquinJTN · Traditional | 05/06/1992SE |
| K910412 | Floxin Susceptibility Test DisksJTN · Traditional | 02/27/1991SE |
| K903968 | Toxo-CubeLGD · Traditional | 12/18/1990SE |
| K901784 | Dryslide, Beta-LactamaseJTO · Traditional | 06/20/1990SE |
| K902082 | Zefazone Susceptibility Test DisksJTN · Traditional | 06/15/1990SE |
| K901371 | Aso-Cube(Tm)GTQ · Traditional | 05/15/1990SE |
| K895215 | Pasco Mic/Id Gram-Positive PanelJWY · Traditional | 01/29/1990SE |
| K896398 | Difco Oxidase DryslideJTO · Traditional | 12/18/1989SE |
| K894829 | Cefixime 5 MCG Sensitivity DisksJTN · Traditional | 09/08/1989SE |
| K893669 | Cellmatics Shlamydia Detection SystemLKH · Traditional | 06/23/1989SE |
| K892051 | Rubella-Cube(Tm)LFX · Traditional | 06/08/1989SE |
| K884842 | Cmv-Cube(Tm)LFZ · Traditional | 04/11/1989SE |
| K890991 | Mono-Cube(Tm)KTN · Traditional | 03/16/1989SE |
| K890339 | Difco Director Inoculation SystemLIE · Traditional | 02/07/1989SE |
| K884017 | RotacubeLIQ · Traditional | 01/24/1989SE |
| K884761 | Modified Cell-Matics Herpes Simplex Virus Detect.GQN · Traditional | 12/05/1988SE |
| K873829 | Cipro Sensitivity DisksJTN · Traditional | 10/02/1987SE |
| K872938 | Ampiciillin Sulbactam 20MCG Sensitivity DisksJTN · Traditional | 08/06/1987SE |
| K871709 | Anaerobic Transport Pouch (Catalyst-Free)KZJ · Traditional | 05/15/1987SE |
| K871606 | Spottest Flagella StainJTS · Traditional | 05/15/1987SE |
| K870201 | Dispens-O-Disc Broth Elution Disks Metron. 80 MCGJTN · Traditional | 04/29/1987SE |
| K870175 | Broth Elution Disks Clindamycin 10MCGJTN · Traditional | 04/29/1987SE |
| K870854 | Bacto(R) Strep Group KitGTZ · Traditional | 04/28/1987SE |
| K870717 | Spottest MicrodaseJTO · Traditional | 04/03/1987SE |
| K870716 | Spottest 10% Sodium DesoxycholateJTO · Traditional | 04/03/1987SE |
| K870348 | Norfloxacin 10 MCG Sensitivity DisksJTN · Traditional | 03/17/1987SE |
| K870347 | Aztreonam 30 MCG Sensitivity DisksJTN · Traditional | 03/05/1987SE |
| K870449 | Spottest Pyr ReagentJTO · Traditional | 02/26/1987SE |
| K862321 | Cellmatics RSV Detection SystemLKT · Traditional | 08/21/1986SE |
| K862320 | Difco Chlamydia Direct Detection SystemLJP · Traditional | 08/19/1986SE |
| K862570 | Dispens-O-Disc Differentiation Disks PyrJTO · Traditional | 07/17/1986SE |
| K861080 | Cellematics Viral/Chlamydal Transport Pack(Modifi)JSM · Traditional | 04/07/1986SE |
| K860905 | UricheckJXA · Traditional | 04/04/1986SE |
| K854978 | Difco Strep a Latex TestGTZ · Traditional | 03/18/1986SE |
| K860795 | Spottest Calcofluor White ReagentLED · Traditional | 03/12/1986SE |
| K860565 | Differentiation Disks Kanamycin 1000 MCGJTO · Traditional | 03/11/1986SE |
| K860564 | Differentiation Disks Erythromycin 60 MCGJTO · Traditional | 03/11/1986SE |
| K860563 | Differentiation Disks Vancomycin 5 MCGJTO · Traditional | 03/11/1986SE |
| K860562 | Differentiation Disks Colistin 10 MCGJTO · Traditional | 03/11/1986SE |
| K860561 | Differentiation Disks Penicillin G 2 UnitsJTO · Traditional | 03/11/1986SE |
| K860560 | Differentiation Disks Rifampin 15 MCGJTO · Traditional | 03/11/1986SE |
| K860179 | Cellmatics Chlamydia Monoclonal Dfa ReagentLJP · Traditional | 03/10/1986SE |
| K855207 | Imipenem 10 MCG Sensitivity DiscsJTT · Traditional | 03/06/1986SE |
| K860527 | Cefotetan 30 MCG Sensitivity DiscsJTN · Traditional | 03/03/1986SE |
| K860293 | Cellmatic Chlamydia Culture Confirm-Mccoy CellsKIR · Traditional | 02/05/1986SE |
| K860292 | Cellmatic Chlamydia Culture CONFIRM-DIFCO-1000KIR · Traditional | 02/05/1986SE |
| K855206 | Cefaclor 30 MCG Sensitivity DiscsJTN · Traditional | 01/24/1986SE |
| K852835 | Ceftazidime 30 MCG Sensitvity DiscsJTN · Traditional | 08/12/1985SE |
| K852423 | Timentin 85MCG Sensitivity Disc · Traditional | 07/16/1985SE |
| K851372 | Cellmatics Herpes Simplex Virus Detect-SysGQL · Traditional | 07/12/1985SE |
| K851481 | Spottest Iodine Solution Dobell & O'ConnorLED · Traditional | 04/29/1985SE |
| K851184 | Spottest India InkJTO · Traditional | 04/01/1985SE |
| K850606 | Ceftriaxone 30 MCG Sensitivity DiscsJTN · Traditional | 04/01/1985SE |
| K850607 | Amdinocillin 10 MCG Sensitivity DiscsJTN · Traditional | 03/20/1985SE |
| K840366 | Cell-Matics Herpes Simplex Virus DetectKIR · Traditional | 01/08/1985SE |
| K843919 | Spottest Loeffler Methylene Blue StainKFC · Traditional | 10/30/1984SE |
| K843521 | Differentiation Disks NitrateJTO · Traditional | 10/02/1984SE |
| K843560 | Bacto Staphylococcus Latex TestJWX · Traditional | 10/01/1984SE |
| K843364 | Differentiation Disks Bile EsculinJSF · Traditional | 09/07/1984SE |
| K843172 | Augmentin 30 MCG Sensitivity DisksJTN · Traditional | 09/07/1984SE |
| K843173 | Cell-Matics Viral Transport PackJTW · Traditional | 09/06/1984SE |
| K842292 | Cefonicid 30 MCG Sensitivity DiscsJTN · Traditional | 07/26/1984SE |
| K842086 | Spottest Lactophenol Cotton Blue StainJTO · Traditional | 07/03/1984SE |
| K842291 | Spot Test Catalase TestJSF · Traditional | 06/22/1984SE |
| K842290 | Spot Test Ninhydrin ReagentsJSF · Traditional | 06/22/1984SE |
| K841453 | Differentiation Disks SpectinomycinJTO · Traditional | 05/02/1984SE |
| K841454 | RF Test KitDHR · Traditional | 04/25/1984SE |
| K834582 | Detect Group a Strep TestGTZ · Traditional | 04/04/1984SE |
| K840896 | Differentiation Disks AlaJTO · Traditional | 03/23/1984SE |
| K840804 | Differentiation Disks SPSJTO · Traditional | 03/23/1984SE |
| K840699 | CRP Slide Test KitDCN · Traditional | 03/23/1984SE |
| K840584 | Spottest Acridine Orange StainJTO · Traditional | 03/02/1984SE |
| K840583 | Spottest Voges-Proskauer Reagent BJTO · Traditional | 02/27/1984SE |
| K840582 | Spottest Ferric Chloride ReagentJTO · Traditional | 02/27/1984SE |
| K840581 | Spottest Nitrate Reagent CJTO · Traditional | 02/27/1984SE |
| K840580 | Spottest Nitrate Reagent BJTO · Traditional | 02/27/1984SE |
| K840579 | Spottest Nitrate Reagent aJTO · Traditional | 02/27/1984SE |
| K840578 | Spottest Voges-Proskauer Reagent aJTO · Traditional | 02/27/1984SE |
| K840577 | Spottest Kovacs' Indole ReagentJTO · Traditional | 02/27/1984SE |
| K840576 | Spottest Dmaca Indole ReagentJTO · Traditional | 02/27/1984SE |
| K840575 | Spottest Oxidase ReagentJTO · Traditional | 02/27/1984SE |
| K834581 | Differentiation Disks HippurateJTO · Traditional | 02/13/1984SE |
| K833416 | Ceftizoxime 30 MCG Sensitivity DiscsJTN · Traditional | 01/11/1984SE |
| K833415 | Ticarcillin 75MCG. Sensitivity DiscsJTN · Traditional | 01/11/1984SE |
| K833414 | Azlocillin 75MCG. Sensitivity DiscsJTN · Traditional | 01/11/1984SE |
| K833900 | Bactrol TB Slide · Traditional | 12/22/1983SE |
| K833901 | Bactrol Gram SlideJTO · Traditional | 12/08/1983SE |
| K832910 | Defazolin 30MCG. Sensitivity DiscsJTN · Traditional | 11/14/1983SE |
| K832909 | Cefuroxime 30MCG. Sensitivity DiscsJTN · Traditional | 10/14/1983SE |
| K830956 | Netilmicin 30MCG. Sensitivity DiscsJTN · Traditional | 04/27/1983SE |
| K821262 | Cefoperazone 75MCG Sensit- DiscsJTN · Traditional | 06/22/1982SE |
| K812524 | Piperacillin 100 Mcg. Sensitivity DiscsJTN · Traditional | 01/28/1982SE |
| K812228 | Moxalactam 30 Mcg. Sensitivity DiscsJTN · Traditional | 10/28/1981SE |
| K812525 | Mezlocillin 75 Mcg. Sensitivity DiscsJTN · Traditional | 10/02/1981SE |
| K810546 | Cefotaxime 30 Mcg. Sensitivity Discs.JTN · Traditional | 03/31/1981SE |
| K802178 | Minocycline 30 Mcg. Sensitivity DiscsJTN · Traditional | 10/10/1980SE |
| K801474 | Trimethoprim 5MCG. Sensitivity DiscsJTN · Traditional | 08/13/1980SE |
| K801473 | Cinoxacin 100 Mcg. Sensitivity DiscsJTN · Traditional | 07/28/1980SE |
| K791897 | Bacto-HattsGMT · Traditional | 11/13/1979SE |