Identity
- Trade Name
- CMV IgG Control FDA UDI
- Generic Name
- Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, control FDA UDI
- Model / Reference
- CMG-2020 FDA UDI
Identifiers
- Catalog Number
- CMG-2020 FDA UDI
- Primary DI / UDI-DI
- B110CMG20200 FDA UDI
- 510(k) Number
- K880679 FDA UDI
- FDA Product Code
- GQH FDA UDI
- GMDN Term
- Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3175 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: Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, control
CMV IgG Control by Bion Enterprises, Ltd. — Class II — 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
- Alinity — Abbott Ireland Diagnostics · Class I
- PreciControl CMV IgG — Roche Diagnostics Corp. · Class I
- LIAISON® CMV IgG Serum Control Set — Diasorin Inc.
- PreciControl Anti-CMV — Roche Diagnostics Corp. · Class II
- BioPlex 2200 — Bio-Rad Laboratories · Class I
- ADVIA Centaur CMV IgG QC — Siemens Healthcare Diagnostics · Class II
- BioPlex 2200 — Bio-Rad Laboratories · Class I
Cleared under the same submission
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
- Bion Enterprises, Ltd.
Sources (1)
- FDA UDI c2b59b00-aa40-4abb-9b8a-5eb1a7d05929 36 fields · synced Jun 1, 2026