Identity
- Trade Name
- BIOPHEN Heparin Calibrator FDA UDI
- Generic Name
- Heparin anti-Xa IVD, calibrator FDA UDI
- Model / Reference
- 222001 FDA UDI
Identifiers
- Catalog Number
- 222001 FDA UDI
- Primary DI / UDI-DI
- 03663537008245 FDA UDI
- 510(k) Number
- K051472 FDA UDI
- FDA Product Code
- GGN FDA UDI
- GMDN Term
- Heparin anti-Xa IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.5425 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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
BIOPHEN Heparin Calibrator by Hyphen Biomed — 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
- STA® - Hepanorm® HBPM/LMWH — DIAGNOSTICA STAGO, INC. · Class II
- INNOVANCE Heparin Calibrator — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- Calibration Plasma LMW Heparin — INSTRUMENTATION LABORATORY COMPANY · Class II
- BIOPHEN UFH Calibrator — HYPHEN BIOMED · Class II
Cleared under the same submission
K051472 also covers:
- BIOPHEN LMWH CONTROL LOW CI — HYPHEN BIOMED
- BIOPHEN LMWH CONTROL LOW CII — HYPHEN BIOMED
- BIOPHEN LMWH Control C3 — HYPHEN BIOMED
- BIOPHEN LMWH Control C4 — HYPHEN BIOMED
- BIOPHEN LMWH Control Low — HYPHEN BIOMED
- BIOPHEN LMWH Control Plasma — HYPHEN BIOMED
- BIOPHEN UFH CONTROL C2 — HYPHEN BIOMED
- BIOPHEN UFH Calibrator — HYPHEN BIOMED
- BIOPHEN UFH Control C1 — HYPHEN BIOMED
- BIOPHEN UFH Control Plasma — HYPHEN BIOMED
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
- Hyphen Biomed
Sources (1)
- FDA UDI c64a5a87-b7c9-4492-85e5-1b9184abb798 35 fields · synced May 30, 2026