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GSP Neonatal Total Galactose kit

FDA UDIEUDAMED

Class I (US FDA UDI)

by Wallac, Inc.

Identity

Trade Name
GSP Neonatal Total Galactose kit FDA UDI
Generic Name
Total galactose IVD, kit, enzyme fluorescence FDA UDI
Device Name
For the quantitative determination of total galactose concentration in dried blood. Note: Kit contains multiple packages. FDA UDI
Model / Reference
3309-002U FDA UDI
Description
For the quantitative determination of total galactose concentration in dried blood. Note: Kit contains multiple packages. FDA UDI

Identifiers

Catalog Number
3309-002U FDA UDI
Primary DI / UDI-DI
06438147367917 FDA UDI
510(k) Number
K190335 FDA UDI
FDA Product Code
JIA FDA UDI
GMDN Term
Total galactose IVD, kit, enzyme fluorescence FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1310 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: Total galactose IVD, kit, enzyme fluorescence

GSP Neonatal Total Galactose kit by Wallac, Inc. — Class I — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Total galactose IVD, kit, enzyme fluorescence.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

IVDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Wallac, Inc.

Sources (2)

  • FDA UDI 0ba67f14-b1a3-4784-ac1e-b003aeb99b73 36 fields · synced Jun 18, 2026
  • EUDAMED 1 fields · synced Jun 3, 2026