API® Coryne
API Coryne is a standardized system for the identification of coryneform bacteria in 24 hours
4manufacturers in China registered for this device type
1catalogue number
13recalls on this code
Who Else Makes It
Concentrated in Jiangsu (1), Shandong (1), Jilin (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Jinan Babio Biotechnology Co., Ltd. | Jinan | Shandong | Manufacturer | 25 |
| Changchun LYZ Technology Co., Ltd. | Changchun | Jilin | Manufacturer | 16 |
| Zhejiang Joozena Medical Technology Co., Ltd. | Dongyang City, Jinhua | Zhejiang | Manufacturer | 5 |
Record
| Listed by | bioMerieux, Inc., United States |
|---|---|
| FDA product code | JTO |
| Device type | Discs, Strips And Reagents, Microorganism Differentiation |
| Device class | Class 1 |
| Regulation | 21 CFR 866.2660 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-04-10 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 20900 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Remel | Remel, Inc. | 62 |
| Discs, Strips And Reagents, Microorganism Differentiation | Hardy Diagnostics | 37 |
| HardyDisk™ | Hardy Diagnostics | 17 |
| Bactidrop | Remel, Inc. | 10 |
| Redipor | Analytichem USA, Inc. | 7 |
| BD BBL™ Taxo™ P | Becton, Dickinson AND Company | 4 |
| BD BBL™ Taxo™ A | Becton, Dickinson AND Company | 4 |
| API® NaCl 0.85% Medium | bioMerieux, Inc. | 3 |
| Bacticard | Remel, Inc. | 3 |
| Chemmette Reagents | Microbiologics, Inc. | 2 |
| Optochin | Oxoid, Ltd. | 2 |
| X Factor | Oxoid, Ltd. | 2 |
Showing 12 of 139. All products under Discs, Strips And Reagents, Microorganism Differentiation
Recalls
13 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2022-11-09 | Class II | Storage | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | 1 unit | |
| 2022-11-09 | Class II | Storage | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | 2 units | |
| 2022-11-09 | Class II | Storage | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | 1 unit | |
| 2022-11-09 | Class II | Storage | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | 2 units | |
| 2022-11-09 | Class II | Storage | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | 2 units | |
| 2022-11-09 | Class II | Storage | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | 3 units | |
| 2022-11-09 | Class II | Storage | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | 1 unit | |
| 2022-11-09 | Class II | Storage | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | 5 unit | |
| 2022-11-09 | Class II | Storage | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | 1 unit | |
| 2022-11-09 | Class II | Storage | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | 2 units | |
| 2022-11-09 | Class II | Storage | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | 14 units | |
| 2022-11-09 | Class II | Storage | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | 2 units | |
| 2018-03-23 | Class II | Environmental control | A shipment to Guadeloupe suffered a temperature excursions up to 47.8C, exceeding the acceptable limits. After detection of the issue, Global Supply Chain QA asked the bioMrieux distributor in Guadeloupe to put products in quarantine in Jul | 4 boxes of OXIDASE REAGENT with 50 – 0.75ML bottles | 2020-06-23 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.