Remel
BHI Agar w/SB, Pen, Strep, Cyclo (25ml)10/PK
1manufacturer
132catalogue numbers in this listing
11510(k) clearances naming this product code
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 | JSJ |
| Device type | Culture Media, Selective And Non-Differential |
| Device class | Class 1 |
| Regulation | 21 CFR 866.2360 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-12-30 |
| Record revised | 2025-03-20 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2025-03-24 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| R08530 | In distribution | ||
| R110131 | In distribution | ||
| R01610 | In distribution | ||
| R08068 | In distribution | ||
| R01771 | In distribution | ||
| R111030 | In distribution | ||
| R08608 | In distribution | ||
| R01508 | In distribution | ||
| R01704 | In distribution | ||
| R08708 | In distribution | ||
| R01346 | In distribution | ||
| R01281 | In distribution | ||
| R08602 | In distribution | ||
| R01258 | In distribution | ||
| R01152 | In distribution | ||
| R20260 | In distribution | ||
| R10245 | In distribution | ||
| R08699 | In distribution | ||
| R01790 | In distribution | ||
| R01284 | In distribution | ||
| R01812 | 10 | In distribution | |
| R08726 | In distribution | ||
| R10254 | In distribution | ||
| R060370 | In distribution | ||
| R08574 | In distribution | ||
| R01317 | In distribution | ||
| R01338 | In distribution | ||
| R09322 | In distribution | ||
| R01660 | In distribution | ||
| R01298 | In distribution | ||
| R08600 | In distribution | ||
| R08724 | In distribution | ||
| R01304 | In distribution | ||
| R01505 | In distribution | ||
| R01703 | In distribution | ||
| R01272 | In distribution | ||
| R01043 | In distribution | ||
| R01350 | In distribution | ||
| R01600 | In distribution | ||
| R01342 | In distribution | ||
| R01754 | In distribution | ||
| R01772 | In distribution | ||
| R01575 | In distribution | ||
| R01954 | In distribution | ||
| R01048 | In distribution | ||
| R01333 | In distribution | ||
| R01148 | In distribution | ||
| R08410 | In distribution | ||
| R01270 | In distribution | ||
| R01124 | In distribution | ||
| R01123 | In distribution | ||
| R02118 | In distribution | ||
| R02112 | In distribution | ||
| R01280 | In distribution | ||
| R01144 | In distribution | ||
| R08078 | In distribution | ||
| R08522 | In distribution | ||
| R01274 | In distribution | ||
| R01063 | In distribution | ||
| R01608 | In distribution | ||
| R08080 | In distribution | ||
| R01049 | In distribution | ||
| R08742 | In distribution | ||
| R01770 | In distribution | ||
| R08532 | In distribution | ||
| R01646 | In distribution | ||
| R01339 | In distribution | ||
| R01341 | In distribution | ||
| R01050 | In distribution | ||
| R01506 | In distribution | ||
| R01509 | In distribution | ||
| R01630 | In distribution | ||
| R01142 | In distribution | ||
| R10155 | In distribution | ||
| R01140 | In distribution | ||
| R01776 | In distribution | ||
| R01294 | In distribution | ||
| R01507 | In distribution | ||
| R01662 | In distribution | ||
| R01156 | In distribution | ||
| R01478 | In distribution | ||
| R08072 | In distribution | ||
| R01261 | In distribution | ||
| R08520 | In distribution | ||
| R08092 | Withdrawn | ||
| R08715 | Withdrawn | ||
| R10270 | Withdrawn | ||
| R452652 | Withdrawn | ||
| R08576 | Withdrawn | ||
| R10156 | Withdrawn | ||
| R01775 | Withdrawn | ||
| R10259 | Withdrawn | ||
| R01359 | Withdrawn | ||
| R01804 | Withdrawn | ||
| R20533 | Withdrawn | ||
| R10044 | Withdrawn | ||
| R08073 | Withdrawn | ||
| R10102 | Withdrawn | ||
| R01306 | Withdrawn | ||
| R08070 | Withdrawn | ||
| R08069 | Withdrawn | ||
| R10250 | Withdrawn | ||
| R20261 | Withdrawn | ||
| R09602 | Withdrawn | ||
| R08412 | Withdrawn | ||
| R01264 | Withdrawn | ||
| R450041 | Withdrawn | ||
| R10130 | Withdrawn | ||
| R10055 | Withdrawn | ||
| R01356 | Withdrawn | ||
| R01661 | Withdrawn | ||
| R08730 | Withdrawn | ||
| R10145 | Withdrawn | ||
| R07006 | Withdrawn | ||
| R10103 | Withdrawn | ||
| R10246 | Withdrawn | ||
| R10070 | Withdrawn | ||
| R01334 | Withdrawn | ||
| R09600 | Withdrawn | ||
| R10272 | Withdrawn | ||
| R01047 | Withdrawn | ||
| R10248 | Withdrawn | ||
| R10264 | Withdrawn | ||
| R10131 | Withdrawn | ||
| R060372 | Withdrawn | ||
| R01226 | Withdrawn | ||
| R20532 | Withdrawn | ||
| R01344 | Withdrawn | ||
| R01471 | Withdrawn | ||
| R08697 | Withdrawn | ||
| R01046 | Withdrawn | ||
| R01072 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Culture Media, Selective And Non-Differential | Hardy Diagnostics | 85 |
| Edge Biologicals Inc | Edge Biologicals, Inc. | 17 |
| HardyFlask™ | Hardy Diagnostics | 12 |
| Alpha-Tec Systems | Alpha-Tec Systems, Inc. | 11 |
| Redipor | Analytichem USA, Inc. | 9 |
| AnaeroGRO | Hardy Diagnostics | 3 |
| BD BBL™ Campylobacter Agar with 5 Antimicrobics and 10% Sheep Blood | Becton, Dickinson AND Company | 2 |
| BD BBL™ XLD Agar | Becton, Dickinson AND Company | 2 |
| BD BBL™ Selenite-F Broth | Becton, Dickinson AND Company | 2 |
| BD BBL™ Campy CVA Agar | Becton, Dickinson AND Company | 2 |
| BD BBL™ Mycosel™ Agar Slants | Becton, Dickinson AND Company | 2 |
| BD BBL™ Middlebrook and Cohn 7H10 Agar Slants | Becton, Dickinson AND Company | 2 |
Showing 12 of 92. All products under Culture Media, Selective And Non-Differential
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K880716 | 1988-03-03 |
| K880717 | 1988-03-03 |
| K840890 | 1984-03-23 |
| K840554 | 1984-02-27 |
| K833967 | 1984-01-11 |
| K834068 | 1984-01-03 |
| K802757 | 1981-01-08 |
| K802758 | 1980-12-31 |
| K802571 | 1980-12-16 |
| K792675 | 1980-03-19 |
| K792676 | 1980-01-24 |
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 |
|---|---|---|---|---|
| 2026-02-05 | Class II | Under Investigation by firm | Customer complaints report low to no recovery of Campylobacter Jejuni ATCC 33291 on identified lot of medium. | 97 |
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.