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Pointe Propoxyphene (PPX) Reagent Set
HORIBA INSTRUMENTS INCORPORATED · Model 60-PP0240-100 · UDI-DI 00811727017918
JXN
Prescription
1
510(k) clearances
1
Adverse events
2
Recalls
55
Facilities
Description
Pointe Propoxyphene (PPX) Reagent Set 1 x 100 mL R1, 1 x 37.5 mL R2 The Pointe Propoxyphene (PPX) Reagent Set is intended for the qualitative and semi-quantitative determination of propoxyphene in human urine at a cutoff value of 300 ng/mL. The assay is designed for prescription use with a number of automated clinical chemistry analyzers.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2010-10-04 | Express 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 |
| 2008-05-28 | Sun Biomedical Laboratories, Inc. | Product was sold while the devices were under FDA 510 (k) review, which was subsequently denied. |
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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.