Identity
- Trade Name
- PreciControl CMV IgG FDA UDI
- Generic Name
- Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, control FDA UDI
- Model / Reference
- 4784600160 FDA UDI
Identifiers
- Catalog Number
- 4784600160 FDA UDI
- Primary DI / UDI-DI
- 04015630934539 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Cytomegalovirus (CMV) immunoglobulin G (IgG) 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, control
PreciControl CMV IgG by Roche Diagnostics Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, control.
- Atellica IM CMV IgG Quality Control — Siemens Healthcare Diagnostics · Class II
- CMV Negative Control — BION ENTERPRISES, LTD. · Class II
- CMV IgG Control — BION ENTERPRISES, LTD. · Class II
- Alinity — Abbott Ireland Diagnostics · Class I
- LIAISON® CMV IgG Serum Control Set — Diasorin Inc.
- BioPlex 2200 — Bio-Rad Laboratories · Class I
- ADVIA Centaur CMV IgG QC — Siemens Healthcare Diagnostics · Class II
- BioPlex 2200 — Bio-Rad Laboratories · Class I
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 8eb13e80-4472-4175-994f-5638fdf8f7d3 33 fields · synced Jun 6, 2026