Factor XI Deficient Substrate Plasma

FDA UDI

Class II (US FDA UDI)

by Helena Laboratories, Corp.

Identity

Trade Name: Factor XI Deficient Substrate Plasma FDA UDI
Generic Name: Coagulation factor XI IVD, reagent FDA UDI
Model / Reference: 5196 FDA UDI

Identifiers

Primary DI / UDI-DI: M52551960 FDA UDI
510(k) Number: K792476 FDA UDI
FDA Product Code: GGP FDA UDI
GMDN Term: Coagulation factor XI IVD, reagent FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 864.7290 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

Yes

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: Coagulation factor XI IVD, reagent

Factor XI Deficient Substrate Plasma by Helena Laboratories, Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Coagulation factor XI IVD, reagent.

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George King Factor XI Deficient Plasma — GEORGE KING BIO-MEDICAL, INC. · Class II
George King Factor XI Deficient Plasma — GEORGE KING BIO-MEDICAL, INC. · Class II
George King Factor XI Deficient Plasma — GEORGE KING BIO-MEDICAL, INC. · Class II
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Coagulation Factor XI Deficient Plasma — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II

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: Helena Laboratories, Corp.

Sources (1)

FDA UDI 28979f36-a6f3-42a4-bea8-ec4b4c0f56ea 34 fields · synced Jun 9, 2026