API® 50 CHL Medium
API 50 CHL Medium, for ID of Lactobacillus and related genera, is a ready-to-use allowing fermentation of the 49 carbohydrates on the API 50 CH strip (Ref. 50 300).
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 CHL Medium | 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
1 of these is 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 |
|---|---|---|---|---|---|
| 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.