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PRAS Oral Treponeme Enrichment Broth (OTEB)
ANAEROBE SYSTEMS · Model AS-6035 · UDI-DI 00810048900275
10
510(k) clearances
3,143
Adverse events
2
Recalls
17
Facilities
Description
AS-6035 Oral Treponeme Enrichment Broth (OTEB) is an enriched non-selective medium used for the isolation, cultivation, and maintenance of Treponema spp. from clinical specimens. Pre-reduced anaerobically sterilized (PRAS). 500 mL fill volume. 500mL Pyrex bottle. Slightly turbid light yellow liquid. 1 bottle per pack.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2009-02-19 | Becton Dickinson & Co. | In vitro diagnostic test reagent may contain residual material that inhibits the growth of gram positive/gram negative organisms. |
| 2004-09-27 | Remel, Inc. | The product does not perform as intended with some quality control organisms (Haemophilus influenzae) |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.