Chrysalis Intelligence · Product Codes · MZP

MZP · Unclassified

4 clearances · 3 unique sponsors

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Device class
—
Regulation —
Total clearances
4
2022-11-04 → 2025-11-03
Last 12 months
2
Unique sponsors
3
Classification details
Medical specialty
—
Review panel
—
Regulation number
—
Implant
—
Life-sustain / support
—
GMP exempt
—
Third-party review
—
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Roche Molecular Systems, Inc. 2 1 2025-11-03
Hologic, Inc. 1 0 2024-07-24
Abbott Molecular, Inc. 1 1 2025-09-25
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
87521 CPT — High Hepatitis C virus RNA detection by nucleic acid amplification
Class III

PMA records in this code (26)

DatePMA #SponsorTrade nameType
2021-08-11 P060030-S086 Roche Molecular Systems, Inc. COBAS AmpliPrep/COBAS TaqMan HCV Test v2.0 30-Day Notice
2021-06-02 P150015-S043 Roche Molecular Systems, Inc. cobas HCV Special (Immediate Track)
2021-06-01 P190025-S006 Abbott Molecular, Inc. Alinity m HCV Real-Time Process
2021-04-26 P190025-S004 Abbott Molecular, Inc. Alinity m HCV Real-Time Process
2021-03-09 P060030-S085 Roche Molecular Systems, Inc. COBAS AmpliPrep/COBAS TaqMan HCV Test v2.0 30-Day Notice
2021-03-05 P190025-S005 Abbott Molecular, Inc. Alinity m HCV 30-Day Notice
2021-03-05 P100017-S024 Abbott Molecular, Inc. Abbott RealTime HCV 30-Day Notice
2021-01-19 P190025-S003 Abbott Molecular, Inc. Alinity m HCV 30-Day Notice
2020-12-10 P150015-S042 Roche Molecular Systems, Inc. cobas HCV 30-Day Notice
2020-12-08 P100017-S023 Abbott Molecular, Inc. Abbott RealTime HCV Assay 30-Day Notice
2020-11-02 P150015-S039 Roche Molecular Systems, Inc. cobas HCV Real-Time Process
2020-10-07 P150015-S041 Roche Molecular Systems, Inc. cobas HCV Special (Immediate Track)
2020-08-26 P150015-S040 Roche Molecular Systems, Inc. cobas HCV 30-Day Notice
2020-08-26 P060030-S084 Roche Molecular Systems, Inc. COBAS AmpliPrep/COBAS TaqMan HCV Test, v2.0 30-Day Notice
2020-07-21 P160023-S019 Hologic, Inc. Aptima HCV Quant Dx Assay 30-Day Notice
2020-07-21 P020011-S016 Gen-Probe Aptima HCV RNA Qualitative Assay 30-Day Notice
2020-06-09 P190025-S002 Abbott Molecular, Inc. Alinity m HCV 30-Day Notice
2020-05-14 P150015-S038 Roche Molecular Systems, Inc. cobas HCV 30-Day Notice
2020-05-14 P060030-S083 Roche Molecular Systems, Inc. COBAS® TaqMan® HCV Test, v2.0, for Use with the High Pure System and COBAS® AmpliPrep/ COBAS® TaqMan® HCV Test, v2.0 30-Day Notice
2020-05-06 P190025-S001 Abbott Molecular, Inc. Alinity m HCV 30-Day Notice
2020-03-23 P190025 Abbott Molecular, Inc. Alinity m HCV Original
2020-02-20 P060030-S082 Roche Molecular Systems, Inc. Cobas AmpliPrep/Cobas Taqman HCV Test v2.0 30-Day Notice
2020-02-14 P160023-S017 Hologic, Inc. Aptima HCV Quant Dx Assay 30-Day Notice
2020-02-14 P020011-S015 Gen-Probe Aptima HCV RNA Qualitative Assay 30-Day Notice
2020-02-06 P150015-S037 Roche Molecular Systems, Inc. cobas HCV 30-Day Notice
2020-01-21 P160023-S016 Hologic, Inc. Aptima HCV Quant Dx Assay Real-Time Process
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2025-11-03 K252484 Roche Molecular Systems, Inc. cobas HCV
2025-09-25 K252102 Abbott Molecular, Inc. Alinity m HCV
2024-07-24 K233352 Hologic, Inc. Aptima HCV Quant Dx Assay
2022-11-04 K221007 Roche Molecular Systems, Inc. cobas HCV
Data source: openFDA · Generated 2026-08-27 08:58 · Last ingest 2026-08-27T12:58:10.687222 · Pipeline: Chrysalis Intelligence