Entopsis, Inc.
Medley, FL, US
Entopsis , Inc. appears in FDA device records in Medley, FL. FDA records list no 510(k) clearances, no PMA records and no registered establishments. As of , FDA records show 7 recalls for this company.
FDA records held for this company
- 510(k) clearances
- 0
- PMA records
- 0
- Recall records
- 7
- 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-1301-2023 | PCRopsis Support: a) 1 mL, REF 787001; b) 0.25 mL, REF 787002; c) 25 uL, REF 787003; Improves the functionality of PCRopsis regents for select applications; nucleic acid extraction from a variety of biological samples | Presence of misleading label statements on the product label. | Class II | Open, Classified | |
| Z-1300-2023 | PCRopsis Reagent RVD-RT, IVD: a) 1 mL, REF 78378001; b) 25 mL, REF 78378025; c) 100 mL, REF 78378100; Extraction-free PCR at room temperature; nucleic acid extraction from a variety of biological samples | Presence of misleading label statements on the product label. | Class II | Open, Classified | |
| Z-1299-2023 | PCRopsis Reagent RVD with RVD Enhancer: a) 1 mL, VALIDATION USE ONLY, REF 78336001; b) 25 mL, REF 78336025; c) 100 mL, REF 78336100; Extraction-free PCR from saliva, urine, &swab specimens in transport medium, nucleic acid extraction from a variety of biological samples | Presence of misleading label statements on the product label. | Class II | Open, Classified | |
| Z-1298-2023 | PCRopsis Lysis Beads, IVDD: a) 25 tubes , REF 597000; b) 25 tubes, REF 597825; c) 50 tubes, REF 597850; d) 25 grams, REF 5970025; e) 1000 kilogram, REF 5971000; coated beads that facilitate lysis of microorganisms; nucleic acid extraction from a variety of biological samples | Presence of misleading label statements on the product label. | Class II | Open, Classified | |
| Z-1297-2023 | PCRopsis Activator: a) 1.5mL, REF 228001; b) 0.5mL,REF 228002; nucleic acid extraction from a variety of biological samples | Presence of misleading label statements on the product label. | Class II | Open, Classified | |
| Z-1296-2023 | PCRopsis Reagent Buccal, IVD, REF 282001; Extraction-free PCR from bucca; swabs (no transport medium) ,nucleic acid extraction from a variety of biological samples | Presence of misleading label statements on the product label. | Class II | Open, Classified | |
| Z-1295-2023 | PCRopsis BCSNano (1mL), REF 2276001; nucleic acid extraction from a variety of biological samples | Presence of misleading label statements on the product label. | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain