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US
Last updated May 23, 2026
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Catalogue (74)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| MedTest DX HCG Control Set Level B | HCG-CTLB | FDA UDI | Class I | Active |
| ALP Reagent | ALP505 | FDA UDI | Class II | Unknown |
| Pointe Scientific, Inc. GGT | HG959-1400 | FDA UDI | Class I | Unknown |
| Direct Lipid Control L3 | 3003 | FDA UDI | Class I | Unknown |
| Direct TIBC Calibrators | TIBCC480 | FDA UDI | Class II | Unknown |
| Bun/Bs200 | BUN600 | FDA UDI | Class II | Active |
| ALT Reagent | ALT505 | FDA UDI | Class I | Active |
| Alkaline Phos/ BS480 | ALP480 | FDA UDI | Class II | Unknown |
| MedTest DX HCG Control Set Level A | HCG-CTLA | FDA UDI | Class I | Active |
| Total Bilirubin for the Polychem 180 | TIB505 | FDA UDI | Class II | Unknown |
| Total Bilirubin for the BS200 | TIB600 | FDA UDI | Class II | Unknown |
| MedTest Dx, Inc. autoLDL Cholestrol | LDL480 | FDA UDI | Class I | Unknown |
| MedTest DX Lactate | LAC480 | FDA UDI | Class II | Unknown |
| BUN/Polychem 180 | BUN505 | FDA UDI | Class II | Active |
| MedTest DX Lipoprotein (a) Calibrator for the BS480 | LPAC480 | FDA UDI | Class II | Unknown |
| MedTest DX Alkaline Phosphatase | ALP600 | FDA UDI | Class II | Unknown |
| MedTest DX Total Bilirubin for the BS480 | TIB480 | FDA UDI | Class II | Unknown |
| MedTest DX Total Iron / BS200 | IRO600 | FDA UDI | Class I | Unknown |
| MedTest DX Phosphorus Reagent on the BS200 | PHO600 | FDA UDI | Class I | Unknown |
| C1 Cleaning Solution | C1S500 | FDA UDI | N/A | Unknown |
| MedTest DX Control Level 2 | HEC200 | FDA UDI | Class I | Unknown |
| Direct TIBC Reagent | TIBC480 | FDA UDI | Class I | Unknown |
| Pointe Scientific Cocaine Metabolite Enzyme Immunoassay | K191638 | FDA 510(k) | Class II | Active |
| Pointe Scientific Creatinine Kinase (CK) Reagent Set | K191296 | FDA 510(k) | Class II | Active |
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FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| May 15, 2015 | Z-2768-2015 | — | terminated | Vial to vial variation in the fill volume that could affect control recovery issues and cause a control result to fall outside the suggested recovery ranges. An under-fill of the vials was found ranging as low as 4.63 ml. When used to reconstitute HNC/HEC, control values were shown to be out of range running on the high end. |