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POINTE SCIENTIFIC BUN (Berthelot)
HORIBA INSTRUMENTS INCORPORATED · Model B7551-120 · UDI-DI 00811727010568
CDL
Prescription
1
510(k) clearances
1
Adverse events
1
Recalls
2
Facilities
Description
For in vitro diagnostic use in the quantitative colorimetric determination of urea nitrogen in serum.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2016-07-20 | Sterling Diagnostics, Inc. | Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of the previously extended expiration dates for the kits. |
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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.