← Back to catalogue

Anti-Glypican-3

FDA UDI

Class I (US FDA UDI)

by Biogenex Laboratories, Inc.

Identity

Trade Name
ANTI-GLYPICAN-3 FDA UDI
Generic Name
Glypican-3 IVD, antibody FDA UDI
Model / Reference
MU539-5UC FDA UDI

Identifiers

Catalog Number
MU539-5UC FDA UDI
Primary DI / UDI-DI
00810119673534 FDA UDI
FDA Product Code
MVU FDA UDI
GMDN Term
Glypican-3 IVD, antibody FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.4020 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

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Total Volume — 0.5 Milliliter FDA UDI

Category: Glypican-3 IVD, antibody

Anti-Glypican-3 by Biogenex Laboratories, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Glypican-3 IVD, antibody.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Biogenex Laboratories, Inc.

Sources (1)

  • FDA UDI 335da1bf-7abd-4731-8583-e72ecbf3bcde 36 fields · synced Jun 1, 2026