Chrysalis Intelligence · Product Codes · PQA

PQA · Unclassified

8 clearances · 5 unique sponsors

Device class
Regulation —
Total clearances
8
2021-10-18 → 2026-07-16
Last 12 months
1
Unique sponsors
5
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
Cepheid 3 0 2023-10-19
Becton, Dickinson and Company 2 0 2024-12-19
Geneohm Sciences Canada, Inc. (Bd Life Sciences) 1 0 2021-10-18
Hologic, Inc. 1 0 2024-11-25
Roche Molecular Systems, Inc. 1 1 2026-07-16
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
87491 CPT High Chlamydia trachomatis; nucleic acid detection; amplified probe technique
87492 CPT High Chlamydia trachomatis; nucleic acid detection; direct probe technique
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-07-16 K260021 Roche Molecular Systems, Inc. cobas® BV/CV
2024-12-19 K243725 Becton, Dickinson and Company BD Vaginal Panel
2024-11-25 K243345 Hologic, Inc. Aptima BV Assay; Aptima CV/TV Assay
2023-10-19 K231381 Cepheid Xpert Xpress MVP; GeneXpert Xpress System
2023-03-06 K223653 Becton, Dickinson and Company BD Vaginal Panel
2022-06-07 K221160 Cepheid Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System
2022-02-09 K212213 Cepheid Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System
2021-10-18 K201017 Geneohm Sciences Canada, Inc. (Bd Life Sciences) BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit