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HomeDRG Instruments Gesellschaft mit beschränkter Haftung › T-4 Total ELISA

T-4 Total ELISA

DRG Instruments Gesellschaft mit beschränkter Haftung · Model EIA-4568 · UDI-DI 04048474045680

CDX Prescription
10
510(k) clearances
100
Adverse events
1
Recalls
13
Facilities

Description

The DRG T4 Total ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of total Thyroxin (T4) in serum or plasma (EDTA, lithium heparin or citrate plasma).

Recalls

DateFirmReason
2025-06-04DRG International, Inc.An incoming complaint reported that the expiration date on the kit box label and Certificate of Analysis (CoA) exceeded the shelf life of the standards and control solutions in the

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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.