Remel
LJ Medw/2.5%Ferric Ammon Cit(slant)20/PK
1manufacturer
5catalogue numbers in this listing
1510(k) clearance
1recall
Who Else Makes It
Registered in Shandong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jinan Babio Biotechnology Co., Ltd. | Jinan | Shandong | Manufacturer | 25 |
Record
| Listed by | Remel, Inc., United States |
|---|---|
| FDA product code | KZI |
| Device type | Culture Media, Enriched |
| Device class | Class 1 |
| Regulation | 21 CFR 866.2330 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2023-01-04 |
| Record revised | 2025-03-24 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2025-03-21 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| R08526 | In distribution | |
| R07097 | In distribution | |
| R01349 | In distribution | |
| R07096 | Withdrawn | |
| R08518 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Culture Media, Enriched | Hardy Diagnostics | 55 |
| AnaeroGRO | Hardy Diagnostics | 9 |
| HardyFlask™ | Hardy Diagnostics | 3 |
| Pras Yeast Casitone Fatty Acids Broth w/ Carbohydrates (Ycfac Broth) | Anaerobe Systems | 3 |
| Pras Anaerobic Enrichment Broth (Mtge Broth) | Anaerobe Systems | 3 |
| Pras Oral Treponeme Enrichment Broth (Oteb) | Anaerobe Systems | 3 |
| Redipor | Analytichem USA, Inc. | 3 |
| BD BBL™ Lowenstein-Jensen Medium Slants | Becton, Dickinson AND Company | 2 |
| Pras BRU PEA BBE/LKV Convenience Pack | Anaerobe Systems | 2 |
| Pras Yeast Casitone Fatty Acid Agar w/ Carbohydrates & Sheep Blood (Ycfac-B) | Anaerobe Systems | 2 |
| BD BBL™ Brain Heart Infusion Agar with 5% Sheep Blood Slants | Becton, Dickinson AND Company | 2 |
| BD BBL™ Columbia Agar with 5% Sheep Blood | Becton, Dickinson AND Company | 2 |
Showing 12 of 46. All products under Culture Media, Enriched
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K881995 | 1988-06-02 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2004-09-27 | Not classified | Other | The product does not perform as intended with some quality control organisms (Haemophilus influenzae) | 4,620 units (308 packages) | 2006-04-25 |
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.