← Back to catalogue

3 x 4% E-Gel 48 Gels

FDA UDI

Class II (US FDA UDI)

by Immucor GTI Diagnostics, Inc.

Identity

Trade Name
3 x 4% E-Gel 48 Gels FDA UDI
Generic Name
Multiple human platelet antigen (HPA) typing IVD, kit, multiplex FDA UDI
Device Name
For Use with ThromboType1 FDA UDI
Model / Reference
EGEL48 FDA UDI
Description
For Use with ThromboType1 FDA UDI

Identifiers

Catalog Number
EGEL48 FDA UDI
Primary DI / UDI-DI
10888234500667 FDA UDI
FDA Product Code
MYP FDA UDI
GMDN Term
Multiple human platelet antigen (HPA) typing IVD, kit, multiplex FDA UDI

Classification

Device Class
Class II 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

Yes

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: Multiple human platelet antigen (HPA) typing IVD, kit, multiplex

3 x 4% E-Gel 48 Gels by Immucor GTI Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple human platelet antigen (HPA) typing IVD, kit, multiplex.

Cleared under the same submission

BK050040 also covers:

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
Immucor GTI Diagnostics, Inc.

Sources (1)

  • FDA UDI 2ce6ac99-76c1-4324-aab9-21eb3eef6697 37 fields · synced Jun 1, 2026