Identity
- Trade Name
- PreciControl HTLV FDA UDI
- Generic Name
- Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD, control FDA UDI
- Model / Reference
- 07108133162 FDA UDI
Identifiers
- Catalog Number
- 07108133162 FDA UDI
- Primary DI / UDI-DI
- 07613336183182 FDA UDI
- FDA Product Code
- QHM FDA UDI
- GMDN Term
- Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD, control FDA UDI
Classification
- Device Class
- U FDA UDI
- Regulation Number
- 610.40 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
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: Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD, control
PreciControl HTLV by Roche Diagnostics Corp. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD, control.
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 U | Pending data |
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Manufacturer
- Manufacturer
- Roche Diagnostics Corp.
Sources (1)
- FDA UDI 4c285185-f7da-4c32-bf20-e78fa935722d 33 fields · synced May 30, 2026