BIOPHEN Antithrombin 5

FDA UDI

Class II (US FDA UDI)

by Hyphen Biomed

Identity

Trade Name: BIOPHEN Antithrombin 5 FDA UDI
Generic Name: Antithrombin III (ATIII) IVD, kit, chromogenic FDA UDI
Model / Reference: 221105 FDA UDI

Identifiers

Catalog Number: 221105 FDA UDI
Primary DI / UDI-DI: 03663537008214 FDA UDI
510(k) Number: K043007 FDA UDI
FDA Product Code: JBQ FDA UDI
GMDN Term: Antithrombin III (ATIII) IVD, kit, chromogenic FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 864.7060 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: Antithrombin III (ATIII) IVD, kit, chromogenic

BIOPHEN Antithrombin 5 by Hyphen Biomed — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Antithrombin III (ATIII) IVD, kit, chromogenic.

INNOVANCE Antithrombin — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
INNOVANCE Antithrombin — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
Berichrom Antithrombin III (A) — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
STA® - Stachrom® AT III 3 — DIAGNOSTICA STAGO, INC. · Class II
INNOVANCE® Antithrombin — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
ACTICHROME ATIII KIT — Biomedica ADI Inc. · Class II
TriniCHROM™ Antithrombin Xa — TCOAG IRELAND LIMITED · Class II
Berichrom Antithrombin III (A) — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II

Cleared under the same submission

K043007 also covers:

BIOPHEN Antithrombin 2.5 — 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 f5efb915-a798-4b5f-b695-f0f24c8c148b 35 fields · synced Jun 8, 2026