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Teco Diagnostics Urea Nitrogen (BUN) Reagent Set (Colorimetric Method)

TECO DIAGNOSTICS · Model B551-66 · UDI-DI 10673486001266

CDL Prescription
1
510(k) clearances
1
Adverse events
1
Recalls
2
Facilities

Description

Teco Diagnostics Urea Nitrogen (BUN) Reagent Set (Colorimetric Method) is used for the direct colorimetric determination of Urea Nitrogen (BUN) in human serum or plasma.

Recalls

DateFirmReason
2016-07-20Sterling 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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Data 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.