← Back to catalogue

GSP Neonatal Creatine Kinase -MM kit

FDA UDI

Class II (US FDA UDI)

by Wallac, Inc.

Identity

Trade Name
GSP Neonatal Creatine Kinase -MM kit FDA UDI
Generic Name
Creatine kinase skeletal muscle isoenzyme (CKMM) IVD, kit, fluorescent immunoassay FDA UDI
Device Name
For the quantitative determination of Creatine Kinase -MM (CK-MM) concentration in dried blood. Note: Kit contains multiple packages. FDA UDI
Model / Reference
3311-001U FDA UDI
Description
For the quantitative determination of Creatine Kinase -MM (CK-MM) concentration in dried blood. Note: Kit contains multiple packages. FDA UDI

Identifiers

Catalog Number
3311-001U FDA UDI
Primary DI / UDI-DI
06438147362615 FDA UDI
FDA Product Code
QJE FDA UDI
GMDN Term
Creatine kinase skeletal muscle isoenzyme (CKMM) IVD, kit, fluorescent immunoassay FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1506 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

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: Creatine kinase skeletal muscle isoenzyme (CKMM) IVD, kit, fluorescent immunoassay

GSP Neonatal Creatine Kinase -MM kit by Wallac, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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
Wallac, Inc.

Sources (1)

  • FDA UDI ee98419d-ba50-479d-a94d-429b879db213 35 fields · synced Jun 1, 2026