API® 50 CH
API 50 CH combines 50 biochemical tests for ID of Lactobacillus and related genera as well as Bacillus and related genera, Enterobacteriaceae and Vibrionaceae.
1manufacturer
1catalogue number
1recall
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiaoyue Pharmaceutical (Huizhou) Co., Ltd. | Huizhou | Guangdong | Manufacturer | 9 |
Record
| Listed by | bioMerieux, Inc., United States |
|---|---|
| FDA product code | JSC |
| Device type | Culture Media, General Nutrient Broth |
| Device class | Class 1 |
| Regulation | 21 CFR 866.2350 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-04-10 |
| Record revised | 2024-04-15 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
| Packaging | Pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| API® 50 CH | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Edge Biologicals Inc | Edge Biologicals, Inc. | 32 |
| Culture Media, General Nutrient Broth | Hardy Diagnostics | 26 |
| Redipor | Analytichem USA, Inc. | 21 |
| Pras Dilution Blanks | Anaerobe Systems | 7 |
| Tryptone Soya Broth | Oxoid, Ltd. | 6 |
| Jiaoyue | Jiaoyue Pharmaceuticals (Huizhou) Co., Ltd. | 4 |
| Pras Peptone Yeast Extract Broth (PY) | Anaerobe Systems | 3 |
| Pras Reinforced Clostridial Broth (RCB) | Anaerobe Systems | 3 |
| Cell Pro | Analytichem USA, Inc. | 3 |
| Pras Peptone Yeast Extract Broth w/ Glucose (PYG) | Anaerobe Systems | 3 |
| BD BBL™ Brain Heart Infusion | Becton, Dickinson AND Company | 3 |
| Pras Peptone Yeast Extract Broth w/ Glucose & Tween 80 FA/GLC (PYG Tween FA/GLC) | Anaerobe Systems | 2 |
Showing 12 of 86. All products under Culture Media, General Nutrient Broth
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| bioMerieux, Inc. | UDI-DI | 2021-09-30 | Class II | Material/Component Contamination | There is potential to provide an incorrect organism identification. | 1382 kits | 2024-01-18 |
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.