CRYOcheck™ Low Fibrinogen Control

FDA UDI

Class II (US FDA UDI)

by Precision Biologic

Identity

Trade Name: CRYOcheck™ Low Fibrinogen Control FDA UDI
Generic Name: Fibrinogen assay (factor I) IVD, control FDA UDI
Model / Reference: CCLF-10 FDA UDI

Identifiers

Primary DI / UDI-DI: 00843876000138 FDA UDI
510(k) Number: K951823 FDA UDI
FDA Product Code: GGN FDA UDI
GMDN Term: Fibrinogen assay (factor I) IVD, control 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

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: Fibrinogen assay (factor I) IVD, control

CRYOcheck™ Low Fibrinogen Control by Precision Biologic — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Precision Biologic

Sources (1)

FDA UDI 98d592e2-fe4a-4efa-9346-096deb8555c4 33 fields · synced May 30, 2026