Identity
- Trade Name
- RealTime FDA UDI
- Generic Name
- Cytomegalovirus (CMV) nucleic acid IVD, control FDA UDI
- Device Name
- Abbott RealTime CMV Control Kit FDA UDI
- Model / Reference
- 09N21-080 FDA UDI
- Description
- Abbott RealTime CMV Control Kit FDA UDI
Identifiers
- Catalog Number
- 09N21-080 FDA UDI
- Primary DI / UDI-DI
- 00884999045781 FDA UDI
- PMA Number
- P160044 FDA UDI
- FDA Product Code
- PAB FDA UDI
- GMDN Term
- Cytomegalovirus (CMV) nucleic acid IVD, control 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
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
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, control
RealTime by Abbott Molecular — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cytomegalovirus (CMV) nucleic acid IVD, control.
- Aptima® — Hologic, Inc. · Class II
- ACCURUN® — LGC Clinical Diagnostics, Inc.
- Exact Diagnostics — Exact Diagnostics · Class I
- Simplexa Congenital CMV Positive Control Pack — DiaSorin Molecular LLC · Class II
- Exact Diagnostics — Exact Diagnostics · Class I
- Exact Diagnostics — Exact Diagnostics · Class I
- Alethia™ CMV External Control Kit — MERIDIAN BIOSCIENCE, INC. · Class II
- Panther Fusion® — Hologic, Inc. · Class I
Cleared under the same submission
P160044 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
- Abbott Molecular
Sources (1)
- FDA UDI 565f3eea-5ecd-42de-994e-a917ba9c8c4c 37 fields · synced May 30, 2026