Chrysalis Intelligence · Product Codes · GTY

GTY · Unclassified

3 clearances · 3 unique sponsors

Device class
Regulation —
Total clearances
3
2022-03-16 → 2026-04-30
Last 12 months
2
Unique sponsors
3
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
Healgen Scientific,, LLC 1 0 2022-03-16
Hangzhou AllTest Biotech Co., Ltd. 1 1 2026-04-30
ACON Laboratories, Inc. 1 1 2025-11-26
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
87880 CPT High CPT code for bacterial antigen detection by immunoassay; includes Streptococcus species
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-04-30 K260342 Hangzhou AllTest Biotech Co., Ltd. AllTest Strep A Rapid Test
2025-11-26 K251697 ACON Laboratories, Inc. Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip
2022-03-16 K212623 Healgen Scientific,, LLC Healgen Strep A Rapid Test Strip (Throat Swab)