6 results
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12ms
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Sources: EU EUDAMED, US FDA
Immutest 10 Pnl Drug Screen Cup w/ Adult, Item No. IMCA-10M5; Immutest 11 Pnl Drug Screen Cup w/ Adult, Item No. IMCA-11OP; Immutest 12 Panel Cup w/Adulteration, Item No. IMCA-12BUP; Immutest 5 panel, Item No. IMCA-5AB-W; Immutest 5 Pnl Drug Cup w/ Adult -waived, Item No. IMCA-5AB-W; Immutest 7 panel, Item No. IMCA-7P; ImmuTest Cup 7-panel w/ Adulteration, Item No. IMCA-7P These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use. ¿¿¿
FDA Enforcement
Class II
·Terminated·Ameditech Inc·November 25, 2015
Immutest 11 Pnl Drug Screen Cup w/ Adult, Item No. IMCA-11OP
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
Immutest 10 Pnl Drug Screen Cup w/ Adult, Item No. IMCA-10M5
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
Immutest 5 Pnl Drug Cup w/ Adult -waived, Item No. IMCA-5AB-W
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
ANSPACH - 2.3MM Fluted Matchstick, Extends 22MM; REF S-8N-L-G1 Cutting shaping bone including spine and cranium.
FDA Enforcement
Class II
·Terminated·The Anspach Effort, Inc.·August 5, 2015
Anspach Single Use Sterile Bone Cutting Burs and Irrigation Clips. Rx Only
FDA Enforcement
Class II
·Terminated·The Anspach Effort, Inc.·January 22, 2014