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von Willebrand Factor Antigen ELISA Kit (96 tests)

FDA UDI

Class II (US FDA UDI)

by Helena Laboratories, Corp.

Identity

Trade Name
von Willebrand Factor Antigen ELISA Kit (96 tests) FDA UDI
Generic Name
Coagulation factor VIII-associated antigen IVD, kit, enzyme immunoassay (EIA) FDA UDI
Model / Reference
5290 FDA UDI

Identifiers

Primary DI / UDI-DI
M52552900 FDA UDI
510(k) Number
K972005 FDA UDI
FDA Product Code
GGP FDA UDI
GMDN Term
Coagulation factor VIII-associated antigen IVD, kit, enzyme immunoassay (EIA) 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Coagulation factor VIII-associated antigen IVD, kit, enzyme immunoassay (EIA)

von Willebrand Factor Antigen ELISA Kit (96 tests) by Helena Laboratories, Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Coagulation factor VIII-associated antigen IVD, kit, enzyme immunoassay (EIA).

Cleared under the same submission

K972005 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Helena Laboratories, Corp.

Sources (1)

  • FDA UDI e032680d-22b0-45cd-86e7-8dbe03819c17 34 fields · synced Jun 9, 2026