API® M Medium
API M Medium allows the differentiation between motile and non-motile bacteria of the facultative aero-anaerobic group. It can be used to complement the API 20 E strip.
2manufacturers in China registered for this device type
1catalogue number
12510(k) clearances naming this product code
Who Else Makes It
Concentrated in Shandong (1), Shaanxi (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jinan Babio Biotechnology Co., Ltd. | Jinan | Shandong | Manufacturer | 25 |
| Xian Tianlong Science AND Technology Co., Ltd. | Xi’An | Shaanxi | Manufacturer | 8 |
Record
| Listed by | bioMerieux, Inc., United States |
|---|---|
| FDA product code | JSH |
| Device type | Culture Media, Non-Selective And Differential |
| Device class | Class 1 |
| Regulation | 21 CFR 866.2320 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-04-10 |
| Record revised | 2026-01-21 (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® M Medium | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Remel | Remel, Inc. | 67 |
| Culture Media, Non-Selective And Differential | Hardy Diagnostics | 63 |
| Edge Biologicals Inc | Edge Biologicals, Inc. | 29 |
| Redipor | Analytichem USA, Inc. | 20 |
| Cystine Lactose Electrolyte Deficient (Cled) Agar | Neogen Technologies, Inc. | 5 |
| Select | BIO-RAD | 3 |
| Spectra | Remel, Inc. | 3 |
| Pras Chopped Meat Medium w/ Glucose (CMG) | Anaerobe Systems | 3 |
| HardyCHROM | Hardy Diagnostics | 3 |
| Pras Chopped Meat Medium (CM) | Anaerobe Systems | 3 |
| Pras Chopped Meat Medium w/ Carbohydrates (CMC) | Anaerobe Systems | 3 |
| BD BBL™ Urea Agar Slants | Becton, Dickinson AND Company | 2 |
Showing 12 of 84. All products under Culture Media, Non-Selective And Differential
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K871095 | 1987-04-03 |
| K844548 | 1985-01-16 |
| K844531 | 1985-01-07 |
| K844513 | 1985-01-07 |
| K844532 | 1985-01-07 |
| K844520 | 1985-01-07 |
| K844521 | 1985-01-07 |
| K844522 | 1985-01-07 |
| K844519 | 1985-01-07 |
| K844516 | 1985-01-07 |
| K844514 | 1985-01-07 |
| K830073 | 1983-02-09 |
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.