Identity
- Trade Name
- artus® CMV RGQ MDx Kit FDA UDI
- Generic Name
- Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Model / Reference
- 1 FDA UDI
Identifiers
- Catalog Number
- 4503245 FDA UDI
- Primary DI / UDI-DI
- 04053228002086 FDA UDI
- PMA Number
- P130027 FDA UDI
- FDA Product Code
- PAB FDA UDI
- GMDN Term
- Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3180 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
Yes
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) nucleic acid IVD, kit, nucleic acid technique (NAT)
artus® CMV RGQ MDx Kit by Qiagen, Inc. — Class II — 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 Primer Mix ASR - 48 Reactions — ELITechGroup MDX LLC. · Class I
- 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
- cobas CMV — Roche Molecular Systems, Inc. · Class II
- Aptima® — Hologic, Inc. · Class II
- cobas® CMV — Roche Molecular Systems, Inc. · Class II
- MGB Alert® CMV 3.0 Probe Mix ASR - 48 Reaction — ELITechGroup MDX LLC. · Class I
Cleared under the same submission
P130027 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Qiagen, Inc.
Sources (1)
- FDA UDI 200eee08-c7a9-4a21-a8e7-e0cb2c8ea93f 34 fields · synced Jun 1, 2026