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Status DS™ 8 card

PRINCETON BIOMEDITECH CORPORATION · Model DOA-280-10-01 · UDI-DI 10743816000440

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1
510(k) clearances
5
Adverse events
1
Recalls
95
Facilities

Description

Status DS™ T/O/C/A//BZ/BA/TC/P card; 10 Test kit

Recalls

DateFirmReason
2005-05-31Applied Biotech IncThe firm has discovered that a number of distributed devices of the Medplus ER Drug Screen Test may be incorrectly assembled which may give incorrect results. The product is an in

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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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.