Identity
- Trade Name
- RealTime FDA UDI
- Generic Name
- PCR/NAT protease reagent IVD FDA UDI
- Device Name
- Abbott Proteinase K Recombinant, PCR Grade FDA UDI
- Model / Reference
- 03L78-061 FDA UDI
- Description
- Abbott Proteinase K Recombinant, PCR Grade FDA UDI
Identifiers
- Catalog Number
- 03L78-061 FDA UDI
- Primary DI / UDI-DI
- 00884999046603 FDA UDI
- PMA Number
- P080026 FDA UDI
- FDA Product Code
- PAB FDA UDI
- GMDN Term
- PCR/NAT protease reagent IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3180 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: PCR/NAT protease reagent IVD
RealTime by Abbott Molecular — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as PCR/NAT protease reagent IVD.
- QIAGEN Proteinase K — Qiagen, Inc. · Class I
- m2000 — Abbott Molecular · Class I
Cleared under the same submission
P080026 also covers:
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 II | Pending data |
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Manufacturer
- Manufacturer
- Abbott Molecular
Sources (1)
- FDA UDI 0391e32f-ff2d-4609-b474-756a1c0892dc 37 fields · synced May 30, 2026