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Alere iScreen Dx
Instant Technologies, Inc. · Model IS1 PCP-DX · UDI-DI 00817405020034
LCM
Prescription
1
510(k) clearances
5
Adverse events
1
Recalls
94
Facilities
Description
Urine Drug Screen Card for detection of Phencyclidine (PCP) single drug, CLIA Waived
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2005-05-31 | Applied Biotech Inc | The 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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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.