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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
3093-004U 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
3093-004U FDA UDI
Primary DI / UDI-DI
06438147411672 FDA UDI
510(k) Number
K173829 FDA UDI
FDA Product Code
PQT FDA UDI
PQU FDA UDI
PQV FDA UDI
PQW FDA UDI
QCL FDA UDI
QCM 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 7ded28ac-8aab-4ebd-92be-2893ad4c4e87 36 fields · synced Jun 6, 2026