Entopsis , Inc.
7 FDA 510(k) clearances · Recalling firm
| Record | Firm | Date |
|---|---|---|
| PCRopsis BCSNano (1mL), REF 2276001; nucleic acid extraction from a variety of biological recall (Z-1295-2023) | Entopsis , Inc. | 2023-03-29 |
| PCRopsis Reagent Buccal, IVD, REF 282001; Extraction-free PCR from bucca; swabs (no transp recall (Z-1296-2023) | Entopsis , Inc. | 2023-03-29 |
| PCRopsis Activator: a) 1.5mL, REF 228001; b) 0.5mL,REF 228002; nucleic acid extraction fro recall (Z-1297-2023) | Entopsis , Inc. | 2023-03-29 |
| PCRopsis Lysis Beads, IVDD: a) 25 tubes , REF 597000; b) 25 tubes, REF 597825; c) 50 tubes recall (Z-1298-2023) | Entopsis , Inc. | 2023-03-29 |
| PCRopsis Reagent RVD with RVD Enhancer: a) 1 mL, VALIDATION USE ONLY, REF 78336001; b) 25 recall (Z-1299-2023) | Entopsis , Inc. | 2023-03-29 |
| PCRopsis Reagent RVD-RT, IVD: a) 1 mL, REF 78378001; b) 25 mL, REF 78378025; c) 100 mL, RE recall (Z-1300-2023) | Entopsis , Inc. | 2023-03-29 |
| PCRopsis Support: a) 1 mL, REF 787001; b) 0.25 mL, REF 787002; c) 25 uL, REF 787003; Impro recall (Z-1301-2023) | Entopsis , Inc. | 2023-03-29 |
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Every clearance here is in the API, with alerts when new ones post.