Chrysalis Intelligence · Product Codes · PAB

PAB · Cytomegalovirus (Cmv) Dna Quantitative Assay

Microbiology · 3 clearances · 3 unique sponsors

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Device class
Class II
Regulation 866.3180
Total clearances
3
2025-01-17 → 2025-11-03
Last 12 months
1
Unique sponsors
3
Definition

What is Cytomegalovirus (Cmv) Dna Quantitative Assay

Cytomegalovirus (CMV) DNA Quantitative Assay is an in vitro nucleic acid assay for the quantitative measurement of CMV DNA in human plasma. The assay can be used to measure CMV DNA levels serially at baseline and during the course of antiviral treatment to assess virological response to treatment. The test results must be interpreted within the context of all relevant clinical and laboratory findings.
Classification details
Medical specialty
Microbiology
Review panel
MI
Regulation number
866.3180
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
N
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Hologic, Inc. 1 0 2025-01-17
Roche Molecular Systems, Inc. 1 1 2025-11-03
Abbott Molecular, Inc. 1 0 2025-07-01
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
87496 CPT — High Cytomegalovirus (CMV) DNA quantitative assay; standard quantitative viral load monitoring code
Class III

PMA records in this code (51)

DatePMA #SponsorTrade nameType
2024-10-23 P210029-S002 Hologic, Inc. Aptima CMV Quant Assay 30-Day Notice
2024-10-10 P160041-S045 Roche Molecular Systems, Inc. COBAS CMV 30-Day Notice
2024-10-04 P160041-S043 Roche Molecular Systems, Inc. cobas CMV 30-Day Notice
2024-10-04 P110037-S064 Roche Molecular Systems, Inc. COBAS AmpliPrep/COBAS TaqMan CMV Test 30-Day Notice
2024-10-02 P160041-S044 Roche Molecular Systems, Inc. cobas CMV 30-Day Notice
2024-09-27 P160041-S046 Roche Molecular Systems, Inc. cobas® CMV 30-Day Notice
2024-09-13 P210022-S012 Abbott Molecular, Inc. Alinity m CMV Assay Real-Time Process
2024-09-11 P160041-S042 Roche Molecular Systems, Inc. cobas CMV 30-Day Notice
2024-09-11 P110037-S063 Roche Molecular Systems, Inc. COBAS AmpliPrep/COBAS TaqMan CMV Test 30-Day Notice
2024-09-05 P210022-S013 Abbott Molecular, Inc. Alinity m CMV Assay Special (Immediate Track)
2024-07-10 P210022-S011 Abbott Molecular, Inc. Alinity m CMV Assay 30-Day Notice
2024-07-01 P160041-S041 Roche Molecular Systems, Inc. cobas CMV 30-Day Notice
2024-02-23 P110037-S062 Roche Molecular Systems, Inc. COBAS® AmpliPrep®, COBAS® TaqMan® CMV Test 30-Day Notice
2024-02-05 P210022-S009 Abbott Molecular, Inc. Alinity m CMV Real-Time Process
2024-01-20 P210022-S010 Abbott Molecular, Inc. Alinity m CMV Assay 30-Day Notice
2024-01-16 P210022-S008 Abbott Molecular, Inc. Alinity m CMV Real-Time Process
2023-12-14 P160041-S040 Roche Molecular Systems, Inc. cobas® CMV 30-Day Notice
2023-12-14 P160041-S039 Roche Molecular Systems, Inc. cobas® CMV 30-Day Notice
2023-12-14 P110037-S061 Roche Molecular Systems, Inc. COBAS® AmpliPrep® / COBAS® TaqMan® CMV Test 30-Day Notice
2023-12-14 P110037-S060 Roche Molecular Systems, Inc. COBAS® AmpliPrep® / COBAS® TaqMan® CMV Test 30-Day Notice
2023-09-14 P210022-S007 Abbott Molecular, Inc. Alinity m CMV 30-Day Notice
2023-08-23 P160041-S038 Roche Molecular Systems, Inc. cobas® CMV 30-Day Notice
2023-08-23 P110037-S059 Roche Molecular Systems, Inc. COBAS® AmpliPrep/COBAS® TaqMan® CMV Test 30-Day Notice
2023-08-17 P160041-S036 Roche Molecular Systems, Inc. cobas® CMV 30-Day Notice
2023-08-17 P110037-S058 Roche Molecular Systems, Inc. COBAS® AmpliPrep, COBAS® TaqMan® CMV Test 30-Day Notice
2023-08-16 P160041-S037 Roche Molecular Systems, Inc. cobas® CMV 30-Day Notice
2023-06-16 P210022-S005 Abbott Molecular, Inc. Alinity m CMV Assay Real-Time Process
2023-03-31 P210022-S004 Abbott Molecular, Inc. Alinity m CMV 30-Day Notice
2023-02-21 P210022-S003 Abbott Molecular, Inc. Alinity m CMV Real-Time Process
2023-01-13 P160044-S005 Abbott Molecular RealTime CMV Assay 30-Day Notice
2022-12-14 P160041-S035 Roche Molecular Systems, Inc. cobas CMV Normal 180 Day Track
2022-11-28 P210022-S002 Abbott Molecular, Inc. Alinity m CMV 30-Day Notice
2022-11-14 P110037-S057 Roche Molecular Systems, Inc. COBAS® AmpliPrep/ COBAS® TaqMan® CMV Test 30-Day Notice
2022-07-20 P210029-S001 Hologic, Inc. Aptima CMV Quant Assay 30-Day Notice
2022-06-09 P160044-S004 Abbott Molecular Abbott RealTime CMV Amplification Kit (09N21-090), Abbott RealTime CMV Control Kit (09N21-080), Abbott RealTime CMV Cali 30-Day Notice
2022-05-26 P210022-S001 Abbott Molecular, Inc. Alinity m CMV 30-Day Notice
2022-05-09 P210029 Hologic, Inc. Aptima CMV Quant Assay Original
2022-05-05 P210022 Abbott Molecular, Inc. Alinity m CMV Original
2022-01-19 P160041-S034 Roche Molecular Systems, Inc. Cobas CMV 30-Day Notice
2021-08-11 P110037-S056 Roche Molecular Systems, Inc. COBAS AmpliPrep/COBAS TaqMan CMV Test 30-Day Notice
2021-06-02 P160041-S033 Roche Molecular Systems, Inc. cobas CMV Special (Immediate Track)
2021-03-09 P110037-S055 Roche Molecular Systems, Inc. COBAS AmpliPrep/COBAS TaqMan CMV Test 30-Day Notice
2021-03-05 P160044-S003 Abbott Molecular Abbott RealTime CMV 30-Day Notice
2020-12-10 P160041-S032 Roche Molecular Systems, Inc. cobas CMV 30-Day Notice
2020-10-07 P160041-S031 Roche Molecular Systems, Inc. cobas CMV Special (Immediate Track)
2020-08-26 P160041-S030 Roche Molecular Systems, Inc. cobas CMV 30-Day Notice
2020-08-26 P110037-S054 Roche Molecular Systems, Inc. COBAS AmpliPrep/COBAS TaqMan CMV Test 30-Day Notice
2020-05-14 P160041-S029 Roche Molecular Systems, Inc. cobas CMV 30-Day Notice
2020-05-14 P110037-S053 Roche Molecular Systems, Inc. COBAS AmpliPrep/COBAS TaqMan CMV Test 30-Day Notice
2020-02-20 P110037-S052 Roche Molecular Systems, Inc. Cobas AmpliPrep/Cobas TaqMan CMV Test 30-Day Notice
2020-02-06 P160041-S028 Roche Molecular Systems, Inc. cobas CMV 30-Day Notice
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2025-11-03 K252481 Roche Molecular Systems, Inc. cobas CMV
2025-07-01 K243485 Abbott Molecular, Inc. Alinity m CMV
2025-01-17 K243935 Hologic, Inc. Aptima CMV Quant Assay
Data source: openFDA · Generated 2026-08-28 09:16 · Last ingest 2026-08-28T13:16:47.116226 · Pipeline: Chrysalis Intelligence