Identity
- Trade Name
- PCRopsis FDA UDI
- Generic Name
- Nucleic acid extraction/isolation kit IVD FDA UDI
- Device Name
- PCRopsis™ Reagent RVD with RVD Enhancer (100 mL) mediates extraction-free RT-qPCR of various specimens transported in compatible transport medium. FDA UDI
- Model / Reference
- Reagent RVD with RVD Enhancer FDA UDI
- Description
- PCRopsis™ Reagent RVD with RVD Enhancer (100 mL) mediates extraction-free RT-qPCR of various specimens transported in compatible transport medium. FDA UDI
Identifiers
- Catalog Number
- 78336100 FDA UDI
- Primary DI / UDI-DI
- B550783361000 FDA UDI
- FDA Product Code
- JJH FDA UDI
- GMDN Term
- Nucleic acid extraction/isolation kit IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2310 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Nucleic acid extraction/isolation kit IVD
PCRopsis by Entopsis, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Entopsis, Llc
Sources (1)
- FDA UDI 1c7c458f-7b01-4d88-96b8-0745de62d96a 34 fields · synced Jun 7, 2026