Chrysalis Intelligence · Product Codes · GGP

GGP · Test, Qualitative And Quantitative Factor Deficiency

Hematology · 7 clearances · 3 unique sponsors

Device class
Class II
Regulation 864.7290
Total clearances
7
2020-07-17 → 2025-08-25
Last 12 months
0
Unique sponsors
3
Medical specialty
Hematology
Review panel
HE
Regulation number
864.7290
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
Y
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Precision Biologic, Inc. 3 0 2025-08-25
Instrumentation Laboratory CO 3 0 2023-12-13
Siemens Healthcare Diagnostics Products GmbH 1 0 2023-06-02
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
85732 CPT High CPT code for prothrombin time and partial thromboplastin time (PT/PTT) testing, standard for coagulation factor deficiency assessment
G0306 HCPCS Complete cbc, automated (hgb, hct, rbc, wbc, without platelet count) and automated wbc differential count ✓ CMS-verified description Medium HCPCS code for certain lab procedures, may apply depending on payer and context
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2025-08-25 K251440 Precision Biologic, Inc. CRYOcheck Chromogenic Factor VIII
2023-12-13 K230852 Instrumentation Laboratory Company HemosIL Chromogenic Factor IX
2023-06-02 K220728 Siemens Healthcare Diagnostics Products GmbH vWF Ag
2022-12-23 K214002 Precision Biologic, Inc. CRYOcheck Chromogenic Factor IX
2022-12-09 K223402 Instrumentation Laboratory CO HemosIL von Willebrand Factor Antigen
2020-08-19 K200033 Instrumentation Laboratory CO HemosIL von Willebrand Factor Antigen
2020-07-17 K193204 Precision Biologic Cryocheck Chromogenic Factor VIII