Spectra
Spectra UTI/Blood Agar Biplate 10/PK
2manufacturers in China registered for this device type
3catalogue numbers in this listing
1510(k) clearance
2recalls on this 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 | Remel, 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 | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-12-22 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| R01818 | In distribution | |
| R01819 | In distribution | |
| R02192 | 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 |
| 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 |
| BD BBL™ TSI 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 |
|---|---|
| K864205 | 1986-11-24 |
Recalls
2 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 |
|---|---|---|---|---|---|
| 2025-07-11 | Class II | Under Investigation by firm | The products may contain surface and subsurface contamination of Listeria monocytogenes. | 1552 units | |
| 2017-03-24 | Class II | Material/Component Contamination | Confirmed complaint of surface contamination of Listeria monocytogenes. | 1,159/100 plates/packs | 2017-06-06 |
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.