Identity
- Trade Name
- Calibration Plasma LMW Heparin FDA UDI
- Generic Name
- Heparin anti-Xa IVD, calibrator FDA UDI
- Device Name
- Calibration Plasma LMW Heparin FDA UDI
- Model / Reference
- 82 3500 63 FDA UDI
- Description
- Calibration Plasma LMW Heparin FDA UDI
Identifiers
- Catalog Number
- 82 3500 63 FDA UDI
- Primary DI / UDI-DI
- 08426950088974 FDA UDI
- 510(k) Number
- K030964 FDA UDI
- FDA Product Code
- JIS FDA UDI
- GMDN Term
- Heparin anti-Xa IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1150 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Heparin anti-Xa IVD, calibrator
Calibration Plasma LMW Heparin by Instrumentation Laboratory Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Heparin anti-Xa IVD, calibrator.
- STA® - Hepanorm® H — DIAGNOSTICA STAGO, INC. · Class II
- INNOVANCE Heparin Calibrator — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- BIOPHEN UFH Calibrator — HYPHEN BIOMED · Class II
- STA® - Hepanorm® HBPM/LMWH — DIAGNOSTICA STAGO, INC. · Class II
- BIOPHEN Heparin Calibrator — HYPHEN BIOMED · Class II
- INNOVANCE Heparin Calibrator — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Instrumentation Laboratory Company
Sources (1)
- FDA UDI a203ef98-3d46-40ca-a92b-554d2708e2fa 37 fields · synced May 30, 2026