Device, General Purpose, Microbiology, Diagnostic
FDA product code LIB · Class I (low risk) · 21 CFR 866.2660 · Microbiology
43510(k) clearances
0PMA approvals
13recalls
Manufacturers
- Dynatech Corp. 10
- Organon Teknika Corp. 4
- Corning Medical & Scientific 3
- Plastic Injectors, Inc. 3
- Portable Medical Laboratories, Inc. 3
- American Dade 2
- Carr-Scarborough Microbiologicals, Inc. 2
- Microtech Medical Systems, Inc. 2
- Osmetech, Inc. 1
- Hexcel Medical 1
- Gull Laboratories, Inc. 1
- Corning Costar Corp. 1
- Mds Laboratories, Inc. 1
- Abco Dealers, Inc. 1
- Dynatech Laboratories, Inc. 1
- Scientific Sales Intl., Inc. 1
- Zimmar Consulting , Ltd. 1
- Gelman Sciences, Inc. 1
- Polymer Technology Corp. 1
- Dr. C.V. Jacob 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K023677 | Osmetech Microbial Analyser-Bacterial Vaginosis (Oma-Bv)LIB · Traditional | Osmetech | 01/29/2003SE |
| K920416 | Supplementary Reagents for Enzygnost/TmbLIB · Traditional | Behring Diagnostics, Inc. | 04/08/1992SE |
| K912558 | Gull ElisawareLIB · Traditional | Gull Laboratories, Inc. | 09/16/1991SE |
| K872273 | Corning Easy Wash Elisa PlatesLIB · Traditional | Corning Medical & Scientific | 07/07/1987SE |
| K871559 | Cell LifterLIB · Traditional | Corning Costar Corp. | 05/15/1987SE |
| K864249 | Normal Saline SterileLIB · Traditional | Mds Laboratories, Inc. | 03/31/1987SE |
| K863789 | Corning Elisa PlatesLIB · Traditional | Corning Medical & Scientific | 10/03/1986SE |
| K862112 | Microscope SlidesLIB · Traditional | Abco Dealers, Inc. | 06/13/1986SE |
| K854604 | Auto MashLIB · Traditional | Dynatech Corp. | 12/06/1985SE |
| K854603 | Multi Mash 2000LIB · Traditional | Dynatech Corp. | 12/06/1985SE |
| K854602 | Mini Mash 2000LIB · Traditional | Dynatech Corp. | 12/06/1985SE |
| K854423 | Immulon 1 Eia Tubes, Immulon 2 Eia TubesLIB · Traditional | Dynatech Laboratories, Inc. | 11/20/1985SE |
| K853285 | Mywasher 5LIB · Traditional | Scientific Sales Intl., Inc. | 10/04/1985SE |
| K853745 | Mic-Concept ViewboxLIB · Traditional | Microtech Medical Systems, Inc. | 09/19/1985SE |
| K850725 | Quadra Titer Micro PlatesLIB · Traditional | Microtech Medical Systems, Inc. | 04/30/1985SE |
| K844476 | Portable Diagnostic LaboratoryLIB · Traditional | Portable Medical Laboratories, Inc. | 03/13/1985SE |
| K844442 | Rapid Diagnostic KitLIB · Traditional | Portable Medical Laboratories, Inc. | 02/01/1985SE |
| K844473 | Hand-Held Slide ReaderLIB · Traditional | Portable Medical Laboratories, Inc. | 01/04/1985SE |
| K843483 | Pharma-Plast Petri DishLIB · Traditional | Zimmar Consulting , Ltd. | 09/21/1984SE |
| K842052 | Giardia GuardLIB · Traditional | Gelman Sciences, Inc. | 09/11/1984SE |
| K842057 | Maclean-Fogg, Dispos-Inocula-LoopsLIB · Traditional | Polymer Technology Corp. | 06/07/1984SE |
| K841632 | Code-A-Well Series 200 PlateLIB · Traditional | Plastic Injectors, Inc. | 05/25/1984SE |
| K841937 | Code-A-Well Series 300 PlateLIB · Traditional | Plastic Injectors, Inc. | 05/22/1984SE |
| K841390 | Code-A-WellLIB · Traditional | Plastic Injectors, Inc. | 05/02/1984SE |
| K833131 | Hcc-Mycobacteria Stain KitLIB · Traditional | Dr. C.V. Jacob | 10/27/1983SE |
| K831641 | Reader Microelisa SystemLIB · Traditional | Organon Teknika Corp. | 08/11/1983SE |
| K832117 | Immulon Substrate Removawell StripsLIB · Traditional | Dynatech Corp. | 08/08/1983SE |
| K831658 | Microelisa CompLIB · Traditional | Organon Teknika Corp. | 07/26/1983SE |
| K831643 | Stripreader Microelisa SystemLIB · Traditional | Organon Teknika Corp. | 07/26/1983SE |
| K831642 | Heating Block Microelisa SystemLIB · Traditional | Organon Teknika Corp. | 07/26/1983SE |
| K831448 | Spia Sys for Solid Phase ImmunoassaysLIB · Traditional | R&D Systems, Inc. | 06/08/1983SE |
| K831450 | Disposable Sterile Filter SystemLIB · Traditional | Corning Medical & Scientific | 06/02/1983SE |
| K823787 | Handi-WashLIB · Traditional | Dynatech Corp. | 03/09/1983SE |
| K823833 | Micro Stix #011-010-5000 & HOLDER#5100LIB · Traditional | Dynatech Corp. | 03/08/1983SE |
| K823557 | Removawell Plate LidLIB · Traditional | Dynatech Corp. | 12/28/1982SE |
| K822962 | Microfluor B Removawell StripsLIB · Traditional | Dynatech Corp. | 11/16/1982SE |
| K822960 | Microfluor B Plate & Micro Fluor W PlateLIB · Traditional | Dynatech Corp. | 11/16/1982SE |
| K822292 | Disposable Dispensing-Spread PipetsLIB · Traditional | American Dade | 08/25/1982SE |
| K820346 | Cali-PipetteLIB · Traditional | Carr-Scarborough Microbiologicals, Inc. | 03/04/1982SE |
| K820345 | Cali-LoopLIB · Traditional | Carr-Scarborough Microbiologicals, Inc. | 03/04/1982SE |
| K820043 | Tek-Pro Tek-Tator V Rotator & HumidifyLIB · Traditional | American Dade | 01/28/1982SE |
| K813640 | Miniwash IILIB · Traditional | Dynatech Corp. | 01/28/1982SE |
| K812068 | Proposed Controls for Dosimetric ReleaseLIB · Traditional | Hexcel Medical | 09/08/1981SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0484-2026 Class II | BD Kiestra" Isolate Suspension Cuvette Array; Catalog No.: 246100;The 2D barcodes on these cuvettes contain formatting errors that prevent the analyzing system from correctly… | Becton Dickinson & Co. | 10/23/2025Open, Classified |
| Z-0756-2016 Class II | API ZYM Bx2 (Ref 70493) Product Usage: ZYM B reagent is an additional test used for…Discrepant identification results related to API identification strips. These discrepant identification… | BioMerieux SA | 01/08/2016Terminated |
| Z-0466-2015 Class II | Oxoid Legionella Latex Test, DR0800M, containing 50 tests per box. The box contains a…A reagent within the test may return false negative results. | Remel Inc | 10/23/2014Terminated |
| Z-0465-2015 Class II | Oxoid Legionella Pneumo Groups 2-14 Latex Test, DR0802M, containing 50 tests per box.…A reagent within the test may return false negative results. | Remel Inc | 10/23/2014Terminated |
| Z-1474-2014 Class II | Oxoid Legionella Pneumo Groups 2-14, DR0802M, containing 50 tests per box. The box…A reagent contained within the product may return false negative results. | Remel Inc | 03/17/2014Terminated |
| Z-1473-2014 Class II | Oxoid Legionella Latex Test, DR0800M, containing 50 tests per box. The box contains a…A reagent contained within the product may return false negative results. | Remel Inc | 03/17/2014Terminated |
| Z-1478-2014 Class II | API Listeria (REF 10300). ZYM B reagent is used and included inside of API NH (REF…bioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB reagent… | BioMerieux SA | 03/06/2014Terminated |
| Z-1477-2014 Class II | API NIH (REF 10400). ZYM B reagent is used and included inside of API NH (REF 10400) and…bioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB reagent… | BioMerieux SA | 03/06/2014Terminated |
| Z-1476-2014 Class II | FB Reagent (REF 70562). FB reagent is an additional test used for revealing the results…bioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB reagent… | BioMerieux SA | 03/06/2014Terminated |
| Z-1475-2014 Class II | ZYM B Reagent (REF 70493). The ZYM B reagent is an additional test used to reveal the…bioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB reagent… | BioMerieux SA | 03/06/2014Terminated |
| Z-1177-2014 Class II | bioMerieux PREVI Isola System (General purpose,microbiology, diagnostic Medical Device)…The firm has determined the product may fail to dispense the sample to the agar plate resulting in a… | Biomerieux Inc | 02/10/2014Terminated |
| Z-1625-2008 | Remel RapID Inoculation Fluid, Microorganism differentiation and identification device…Failure to produce reaction: Use of the product with various RapID Identification systems panels may exhibit… | Remel Inc | 10/23/2007Terminated |
| Z-1624-2008 | Remel RapID Inoculation Fluid, Microorganism differentiation and identification device…Failure to produce reaction: Use of the product with various RapID Identification systems panels may exhibit… | Remel Inc | 10/23/2007Terminated |