Is this your brand? Sign in to claim ownership.
Sign in to claim this brandENTOPSIS, LLC
US
Last updated May 23, 2026
What ENTOPSIS, LLC makes
Entopsis, LLC manufactures nucleic acid extraction and isolation kits designed for in vitro diagnostic (IVD) use. These kits are intended for processing biological samples to isolate nucleic acids, enabling downstream applications such as PCR testing.
The company’s products are classified as Class I medical devices under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 078294784
Catalogue (63)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| PCRopsis | Reagent RVD-E | FDA UDI | Class I | Unknown |
| PCRopsis | Universal Viral Transport (100x 3 mL) | FDA UDI | Class I | Unknown |
| PCRopsis | Lysis Beads | FDA UDI | Class I | Active |
| PCRopsis | Reagent Buccal | FDA UDI | Class I | Unknown |
| OpsisDx | Standard Media | FDA UDI | Class II | Unknown |
| PCRopsis | Elution Buffer | FDA UDI | Class I | Active |
| PCRopsis | Reagent RVD | FDA UDI | Class I | Unknown |
| OpsisDx | Testing Tray | FDA UDI | Class II | Unknown |
| PCRopsis | Support | FDA UDI | Class I | Active |
| PCRopsis | Reagent RVD-WHO | FDA UDI | Class I | Unknown |
| PCRopsis | Activator | FDA UDI | Class I | Unknown |
| PCRopsis | Lysis Beads | FDA UDI | Class I | Active |
| PCRopsis | Reagent RVD-E | FDA UDI | Class I | Unknown |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (7)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Entopsis, LLC has seven recall records, all initiated on February 21, 2023. The records are marked as either open or classified, with the sole reason stated as the presence of misleading label statements on the product label.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Feb 21, 2023 | Z-1299-2023 | — | open, classified | Presence of misleading label statements on the product label. |
| Feb 21, 2023 | Z-1297-2023 | — | open, classified | Presence of misleading label statements on the product label. |
| Feb 21, 2023 | Z-1296-2023 | — | open, classified | Presence of misleading label statements on the product label. |
| Feb 21, 2023 | Z-1298-2023 | — | open, classified | Presence of misleading label statements on the product label. |
| Feb 21, 2023 | Z-1300-2023 | — | open, classified | Presence of misleading label statements on the product label. |
| Feb 21, 2023 | Z-1301-2023 | — | open, classified | Presence of misleading label statements on the product label. |
| Feb 21, 2023 | Z-1295-2023 | — | open, classified | Presence of misleading label statements on the product label. |