Identity
- Trade Name
- PCRopsis FDA UDI
- Generic Name
- Nucleic acid extraction/isolation kit IVD FDA UDI
- Device Name
- PCRopsis™ Pre-Plated Lysis Beads facilitate lysis of difficult to lyse microorganisms in a convenient deep-well, 96-well plate. FDA UDI
- Model / Reference
- Pre-Plated Lysis Beads FDA UDI
- Description
- PCRopsis™ Pre-Plated Lysis Beads facilitate lysis of difficult to lyse microorganisms in a convenient deep-well, 96-well plate. FDA UDI
Identifiers
- Catalog Number
- 7520096 FDA UDI
- Primary DI / UDI-DI
- B55075200960 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
Yes
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 7d3c8428-7f4c-41bd-af55-7af224f11ce6 34 fields · synced May 30, 2026