Company
Entopsis , Inc.
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
7recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JJH | Clinical Sample Concentrator | 7 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 29, 2023 | Entopsis , Inc. 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 o Open, Classified |
JJH | None listed |
| Mar 29, 2023 | Entopsis , Inc. 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 sa Open, Classified |
JJH | None listed |
| Mar 29, 2023 | Entopsis , Inc. 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 transp Open, Classified |
JJH | None listed |
| Mar 29, 2023 | Entopsis , Inc. 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 m Open, Classified |
JJH | None listed |
| Mar 29, 2023 | Entopsis , Inc. PCRopsis Activator: a) 1.5mL, REF 228001; b) 0.5mL,REF 228002; nucleic acid extraction from a variety of biological samples Open, Classified |
JJH | None listed |
| Mar 29, 2023 | Entopsis , Inc. PCRopsis Reagent Buccal, IVD, REF 282001; Extraction-free PCR from bucca; swabs (no transport medium) ,nucleic acid extraction from a variety of biological samples Open, Classified |
JJH | None listed |
| Mar 29, 2023 | Entopsis , Inc. PCRopsis BCSNano (1mL), REF 2276001; nucleic acid extraction from a variety of biological samples Open, Classified |
JJH | None listed |