Chrysalis Intelligence · Product Codes · QLU

QLU · Unclassified

3 clearances · 2 unique sponsors

Device class
Regulation —
Total clearances
3
2020-09-17 → 2024-10-10
Last 12 months
0
Unique sponsors
2
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
Instrumentation Laboratory CO 2 0 2023-06-23
Siemens Healthcare Diagnostics Products GmbH 1 0 2024-10-10
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
85536 CPT Medium Heparin activity measurement; covers direct oral Factor Xa inhibitor monitoring
85732 CPT Medium Prothrombin time, INR/PT; applicable for anticoagulant management testing including Factor Xa inhibitors
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2024-10-10 K240315 Siemens Healthcare Diagnostics Products GmbH INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05)
2023-06-23 K223187 Instrumentation Laboratory CO HemosIL Liquid Anti-Xa
2020-09-17 DEN190032 Instrumentation Laboratory CO HemosIL Liquid Anti-Xa