Biophen Heparin 3

FDA UDI

Class II (US FDA UDI)

by Hyphen Biomed

Identity

Trade Name: BIOPHEN HEPARIN 3 FDA UDI
Generic Name: Heparin anti-Xa IVD, kit, chromogenic FDA UDI
Model / Reference: 221003 FDA UDI

Identifiers

Catalog Number: 221003 FDA UDI
Primary DI / UDI-DI: 03663537008184 FDA UDI
510(k) Number: K050367 FDA UDI
FDA Product Code: KFF FDA UDI
GMDN Term: Heparin anti-Xa IVD, kit, chromogenic FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 864.7525 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Heparin anti-Xa IVD, kit, chromogenic

Biophen Heparin 3 by Hyphen Biomed — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Heparin anti-Xa IVD, kit, chromogenic.

INNOVANCE Heparin — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
Stachrom® Heparin — DIAGNOSTICA STAGO, INC. · Class II
HR-ACT — MEDTRONIC, INC. · Class II
LR-ACT — MEDTRONIC, INC. · Class II
RACT — MEDTRONIC, INC. · Class II
ACTICHROME HEPARIN (ANTI-FXA) — Biomedica ADI Inc. · Class II
Coamatic Heparin — INSTRUMENTATION LABORATORY COMPANY · Class II
STA® - Liquid Anti-Xa 4 — DIAGNOSTICA STAGO, INC. · Class II

Cleared under the same submission

K050367 also covers:

BIOPHEN HEPARIN 6 — 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 205d19fe-4468-46b3-96ad-cd0e19d249fb 35 fields · synced May 30, 2026