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ARK™ Ketamine II Assay
ARK DIAGNOSTICS INC · Model 5083-0001-03 · UDI-DI 00812101031995
LCM
Prescription
10
510(k) clearances
5
Adverse events
1
Recalls
94
Facilities
Description
The ARK Ketamine II Assay is an immunoassay intended for the qualitative detection and/or semi-quantitative estimation of ketamine in human urine at cutoffs of 50 ng/mL and 100 ng/mL.
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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