Identity
- Trade Name
- MGB Alert® CMV 3.0 Primer Mix ASR - 48 Reactions FDA UDI
- Generic Name
- Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- "MGB Alert® CMV 3.0 Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from the IE1 region of CMV (Cytomegalovirus). " FDA UDI
- Model / Reference
- 800413 FDA UDI
- Description
- "MGB Alert® CMV 3.0 Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from the IE1 region of CMV (Cytomegalovirus). " FDA UDI
Identifiers
- Catalog Number
- 800413 FDA UDI
- Primary DI / UDI-DI
- 03661540951473 FDA UDI
- FDA Product Code
- MVU FDA UDI
- GMDN Term
- Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.4020 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
No
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
Yes
FDA UDI
Category: Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT)
MGB Alert® CMV 3.0 Primer Mix ASR - 48 Reactions by ELITechGroup MDX LLC. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT).
- MGB Alert® CMV 3.0 Probe Mix ASR - 480 Reactions QTY-25 — ELITECHGROUP INC. · Class I
- cobas CMV Control Kit — Roche Molecular Systems, Inc. · Class II
- RealTime — Abbott Molecular · Class II
- artus® CMV RGQ MDx Kit — Qiagen, Inc. · Class II
- cobas CMV — Roche Molecular Systems, Inc. · Class II
- Aptima® — Hologic, Inc. · Class II
- cobas® CMV — Roche Molecular Systems, Inc. · Class II
- COBAS® AmpliPrep/ COBAS® TaqMan® CMV Test — Roche Molecular Systems, Inc. · 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 |
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Manufacturer
- Manufacturer
- ELITechGroup MDX LLC.
Sources (1)
- FDA UDI f231ec49-bd1d-4a2f-9f32-cc51d093ee90 36 fields · synced May 30, 2026