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NeoLSD MSMS kit

FDA UDI

Class II (US FDA UDI)

by Wallac, Inc.

Identity

Trade Name
NeoLSD MSMS kit FDA UDI
Generic Name
Newborn metabolic screen/congenital disorder IVD, kit, spectrophotometry FDA UDI
Device Name
For the quantitative measurement of the activity of certain lysosomal enzymes in dried blood spots. Note: Kit contains multiple packages. FDA UDI
Model / Reference
3093-001U FDA UDI
Description
For the quantitative measurement of the activity of certain lysosomal enzymes in dried blood spots. Note: Kit contains multiple packages. FDA UDI

Identifiers

Catalog Number
3093-001U FDA UDI
Primary DI / UDI-DI
06438147356218 FDA UDI
FDA Product Code
PQW FDA UDI
GMDN Term
Newborn metabolic screen/congenital disorder IVD, kit, spectrophotometry FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1488 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: Newborn metabolic screen/congenital disorder IVD, kit, spectrophotometry

NeoLSD MSMS kit by Wallac, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Newborn metabolic screen/congenital disorder IVD, kit, spectrophotometry.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Wallac, Inc.

Sources (1)

  • FDA UDI 9d1db15b-2b28-4d7f-a251-8b7d77bba1f6 35 fields · synced Jun 8, 2026