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NeoBase Non-derivatized MSMS kit

FDA UDI

Class II (US FDA UDI)

by Wallac, Inc.

Identity

Trade Name
NeoBase Non-derivatized MSMS kit FDA UDI
Generic Name
Multiple amino acid/carnitine metabolite IVD, kit, mass spectrometry FDA UDI
Device Name
For the quantitative determination of amino acid, acylcarnitine and free carnitine concentrations in dried blood. FDA UDI
Model / Reference
3040-001U FDA UDI
Description
For the quantitative determination of amino acid, acylcarnitine and free carnitine concentrations in dried blood. FDA UDI

Identifiers

Catalog Number
3040-001U FDA UDI
Primary DI / UDI-DI
06438147311859 FDA UDI
510(k) Number
K083130 FDA UDI
K093916 FDA UDI
FDA Product Code
NQL FDA UDI
GMDN Term
Multiple amino acid/carnitine metabolite IVD, kit, mass spectrometry FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1055 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 amino acid/carnitine metabolite IVD, kit, mass spectrometry

NeoBase Non-derivatized MSMS kit by Wallac, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple amino acid/carnitine metabolite IVD, kit, mass spectrometry.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Wallac, Inc.

Sources (1)

  • FDA UDI 135a3e31-795f-4575-8c60-12e3d8321372 36 fields · synced May 29, 2026