Biophen Plasma Calibrator

FDA UDI

Class II (US FDA UDI)

by Hyphen Biomed

Identity

Trade Name: BIOPHEN PLASMA CALIBRATOR FDA UDI
Generic Name: Plasma protein IVD, calibrator FDA UDI
Model / Reference: 222101 FDA UDI

Identifiers

Catalog Number: 222101 FDA UDI
Primary DI / UDI-DI: 03663537008252 FDA UDI
510(k) Number: K043451 FDA UDI
FDA Product Code: GGN FDA UDI
GMDN Term: Plasma protein 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

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: Plasma protein IVD, calibrator

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

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Cleared under the same submission

K043451 also covers:

BIOPHEN ABNORMAL 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 3db29757-2a20-4a71-91b5-5ff44b70caab 35 fields · synced Jun 6, 2026