Identity
- Trade Name
- CMV Primer ASR FDA UDI
- Generic Name
- Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- The CMV Primer ASR contains a specific nucleic acid sequence for the amplification of cytomegalovirus (CMV). The CMV Primer ASR is designed to detect a 105 bp region of the MIE gene in the CMV genome. The DNA is synthetically derived. Analyte Specific Reagent. Analytical and performance characteristics are not established. FDA UDI
- Model / Reference
- V1 FDA UDI
- Description
- The CMV Primer ASR contains a specific nucleic acid sequence for the amplification of cytomegalovirus (CMV). The CMV Primer ASR is designed to detect a 105 bp region of the MIE gene in the CMV genome. The DNA is synthetically derived. Analyte Specific Reagent. Analytical and performance characteristics are not established. FDA UDI
Identifiers
- Catalog Number
- 1124260 FDA UDI
- Primary DI / UDI-DI
- 04053228040972 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
- Not 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
CMV Primer ASR by Qiagen, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Qiagen, Inc.
Sources (1)
- FDA UDI 932c2ef4-1c10-4b88-8b74-75b7bb99000f 37 fields · synced May 30, 2026