FDA Device Intelligence
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Co-Innovation Biotech Co., Ltd · Model DOA14PC · UDI-DI 06970429841406

JXNLDJLFGLCMDNKDJCDIOJXMDJGDISDKZ Prescription
1
510(k) clearances
1
Adverse events
2
Recalls
55
Facilities

Description

14P Rapid Multi-Drug Test Cup

Recalls

DateFirmReason
2010-10-04Express Diagnostics Int'l., Inc.Express Diagnostics Int'l, Inc (EDI), is recalling DrugCheck Drug Screen Cups containing buprenorphine (BUP) and propoxyphene (PPX) because they must be labeled as "forensic use o
2008-05-28Sun Biomedical Laboratories, Inc.Product was sold while the devices were under FDA 510 (k) review, which was subsequently denied.

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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.