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Teco Diagnostics ALT (SGPT) Reagent Set (Colorimetric, Endpoint Method)

TECO DIAGNOSTICS · Model A526-120 · UDI-DI 10673486013979

CKD Prescription
1
510(k) clearances
2
Adverse events
2
Recalls
7
Facilities

Description

Teco Diagnostics ALT (SGPT) Reagent Set (Colorimetric, Endpoint Method) is used for the quantitative determination of alanine aminotransferase (Glutamate pyruvate transaminase, SGPT) in human serum.

Recalls

DateFirmReason
2013-03-06Alere San Diego, Inc.The recall was initiated because Alere San Diego has an update for the Alere Cholestech LDX ALT AST cassette, and it has the potential for humidity changes to impact results for ce
2004-07-14Roche Diagnostics Corp.Coating defect may result is falsely decreased patient and/or control results.

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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.