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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
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- —
- —
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- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 078294784
Catalogue (63)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| PCRopsis | Lysis Beads | FDA UDI | Class I | Active |
| PCRopsis | Elution Buffer | FDA UDI | Class I | Active |
| PCRopsis | Universal Viral Transport | FDA UDI | Class I | Unknown |
| PCRopsis | Elution Buffer | FDA UDI | Class I | Unknown |
| PCRopsis | BCS Nano | FDA UDI | Class I | Unknown |
| PCRopsis | UrineA | FDA UDI | Class I | Unknown |
| PCRopsis | RVD Enhancer | FDA UDI | Class I | Unknown |
| PCRopsis | Reagent RVD-RT | FDA UDI | Class I | Unknown |
| PCRopsis | Concentrator | FDA UDI | Class I | Unknown |
| OpsisDx | Quality Control Tray | FDA UDI | Class II | Unknown |
| PCRopsis | Reagent RVD with RVD Enhancer | FDA UDI | Class I | Active |
| PCRopsis | Reagent 123 | FDA UDI | Class I | Unknown |
| PCRopsis | Support | FDA UDI | Class I | Active |
| PCRopsis | Pre-Plated Lysis Beads | FDA UDI | Class I | Active |
| PCRopsis | Reagent 123 | FDA UDI | Class I | Unknown |
| PCRopsis | UrineA | FDA UDI | Class I | Unknown |
| PCRopsis | Lysis Beads | FDA UDI | Class I | Active |
| PCRopsis | Reagent 123 | FDA UDI | Class I | Unknown |
| PCRopsis | Reagent Buccal | FDA UDI | Class I | Unknown |
| PCRopsis | Reagent SRVD | FDA UDI | Class I | Unknown |
| PCRopsis | Reagent SRVD | FDA UDI | Class I | Unknown |
| PCRopsis | Concentrator | FDA UDI | Class I | Unknown |
| PCRopsis | Reagent Buccal | FDA UDI | Class I | Unknown |
| PCRopsis | Reagent RVD | FDA UDI | Class I | Unknown |
| PCRopsis | Support | FDA UDI | Class I | Active |
| PCRopsis | RVD Enhancer | FDA UDI | Class I | Unknown |
| PCRopsis | BCS Nano | FDA UDI | Class I | Unknown |
| PCRopsis | Support | FDA UDI | Class I | Active |
| PCRopsis | Elution Buffer | FDA UDI | Class I | Active |
| PCRopsis | Reagent SRVD | FDA UDI | Class I | Unknown |
| PCRopsis | Reagent RVD | FDA UDI | Class I | Unknown |
| PCRopsis | Reagent RVD with RVD Enhancer | FDA UDI | Class I | Active |
| PCRopsis | Activator | FDA UDI | Class I | Unknown |
| OpsisDx | NuTec Chamber | FDA UDI | Class II | Unknown |
| PCRopsis | Universal Viral Transport | FDA UDI | Class I | Unknown |
| PCRopsis | Reagent RVD with RVD Enhancer | FDA UDI | Class I | Active |
| PCRopsis | Universal Viral Transport (100x 1.5 mL) | FDA UDI | Class I | Unknown |
| OpsisDx | Signal Enhancer | FDA UDI | Class II | Unknown |
| PCRopsis | Reagent RVD with RVD Enhancer | FDA UDI | Class I | Active |
| PCRopsis | BCS Nano | FDA UDI | Class I | Unknown |
| PCRopsis | Reagent RVD-RT | FDA UDI | Class I | Unknown |
| PCRopsis | Universal Viral Transport | FDA UDI | Class I | Unknown |
| PCRopsis | Reagent 123 | FDA UDI | Class I | Unknown |
| PCRopsis | Reagent Buccal | FDA UDI | Class I | Unknown |
| PCRopsis | Reagent RVD-E | FDA UDI | Class I | Unknown |
| PCRopsis | Lysis Beads | FDA UDI | Class I | Active |
| PCRopsis | Lysis Beads | FDA UDI | Class I | Active |
| PCRopsis | Reagent RVD-WHO | FDA UDI | Class I | Unknown |
| PCRopsis | Lysis Beads | FDA UDI | Class I | Active |
| PCRopsis | Reagent RVD-RT | FDA UDI | Class I | Unknown |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
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Notified Bodies
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Authorities
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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. |