Identity
- Trade Name
- Aptima® FDA UDI
- Generic Name
- Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- The Aptima® CMV Quant Assay is an in vitro nucleic acid amplification test for the quantitation of human cytomegalovirus (CMV) DNA in human EDTA plasma on the fully automated Panther® system. FDA UDI
- Model / Reference
- KIT, MAIN ASSAY, CMV, 100-TEST, IVD FDA UDI
- Description
- The Aptima® CMV Quant Assay is an in vitro nucleic acid amplification test for the quantitation of human cytomegalovirus (CMV) DNA in human EDTA plasma on the fully automated Panther® system. FDA UDI
Identifiers
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
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) nucleic acid IVD, kit, nucleic acid technique (NAT)
Aptima® by Hologic, 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
- artus® CMV RGQ MDx Kit — Qiagen, Inc. · Class II
- cobas CMV — Roche Molecular Systems, 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
K243935 also covers:
P210029 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 |
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Manufacturer
- Manufacturer
- Hologic, Inc.
Sources (1)
- FDA UDI 1678181c-8fcb-4b31-ac97-dde04a9768d0 37 fields · synced May 30, 2026