Identity
- Trade Name
- PreciControl HIV Gen II FDA UDI
- Generic Name
- HIV1/HIV2 antigen/antibody IVD, control FDA UDI
- Model / Reference
- 06924107160 FDA UDI
Identifiers
- Catalog Number
- 06924107160 FDA UDI
- Primary DI / UDI-DI
- 04015630942503 FDA UDI
- FDA Product Code
- JJY FDA UDI
- GMDN Term
- HIV1/HIV2 antigen/antibody IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 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
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: HIV1/HIV2 antigen/antibody IVD, control
PreciControl HIV Gen II by Roche Diagnostics Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as HIV1/HIV2 antigen/antibody IVD, control.
- GS — Bio-Rad Laboratories · Class II
- LIAISON XL MUREX Control HIV Ab/Ag HT — Diasorin S.P.A
- Alinity — Abbott
- Alinity — Abbott
- ACCESS HIV Ag/Ab combo QC — Beckman Coulter, Inc. · Class I
- BioPlex® 2200 — Bio-Rad Laboratories · Class II
- ADVIA Centaur® CHIV QC — Siemens Healthcare Diagnostics · Class II
- Alinity — Abbott · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Roche Diagnostics Corp.
Sources (1)
- FDA UDI e55d9ca6-73c3-4248-a33e-f49f76a69701 34 fields · synced May 30, 2026