Applied Biotech Inc
San Diego, CA
Applied Biotech Inc appears in FDA device records in San Diego, CA. FDA records list no 510(k) clearances, no PMA records and no registered establishments. As of , FDA records show 4 recalls for this company.
FDA records held for this company
- 510(k) clearances
- 0
- PMA records
- 0
- Recall records
- 4
- Registered establishments
- 0
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
No FDA product codes recorded against this company.
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0245-2008 | Clearview hCG Combo Waived for urine & Moderate for serum, Wampole Laboratories, ABI List No/Product No. 6026KCV; Contents 30 Individually pouched test cassettes with disposable pipettes, 1 Directional Insert; Inverness Medical Professional Diagnostics Group; Marketed by Wampole Laboratories, 2 Research Way, Princeton NJ 08540 USA | Sensitivity: Kits contain test devices which may not meet the label claims for sensitivity, therefore use of such devices may produce false negative results with patient samples at or near the limit of detection of the product. | Terminated | ||
| Z-0244-2008 | Clearview hCG Combo with Reference Line, Wampole Laboratories, ABI List No/Product No. 6028KCV; 30 Individually pouched test cassettes with disposable pipettes, 1 Directional Insert; Inverness Medical Professional Diagnostics Group; Marketed by Wampole Laboratories, 2 Research Way, Princeton NJ 08540 USA | Sensitivity: Kits contain test devices which may not meet the label claims for sensitivity, therefore use of such devices may produce false negative results with patient samples at or near the limit of detection of the product. | Terminated | ||
| Z-1100-06 | Signify hCG Serum/Urine 30 Test Kit, Abbott List No. 07K09-30, ABI List No. 6026KSI, Lot# 84936, Exp 02/10/2007 | Certain kits from the product lot may contain test devices which contain incorrect reaction strips. Use of such devices may produce false negative results with patient samples at and above the limit of detection of the product. | Terminated | ||
| Z-1315-06 | Medplus ER Drug Screen Test Model #5800KAB packaged as 25 individually pouched devices in a labeled kit box. | 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 vitro test for rapid detection of various drugs such as Amphetamines, Barbiturates, Phencyclidine, Cocaine, Methamphetamine, Tricyclic Antidepressants, Morphine, Tetrahydrocannabinol, & Benzodiazepines in human urine. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain