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NeoGram Amino Acids and Acylcarnitines Tandem Mass Spectrometry Kit

FDA UDI

Class II (US FDA UDI)

by Wallac, Inc.

Identity

Trade Name
NeoGram Amino Acids and Acylcarnitines Tandem Mass Spectrometry 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
3026-0030 FDA UDI
Description
For the quantitative determination of amino acid, acylcarnitine and free carnitine concentrations in dried blood. FDA UDI

Identifiers

Catalog Number
3026-0030 FDA UDI
Primary DI / UDI-DI
06438147283835 FDA UDI
510(k) Number
DEN040002 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
Not 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

NeoGram Amino Acids and Acylcarnitines Tandem Mass Spectrometry 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

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Manufacturer

Manufacturer
Wallac, Inc.

Sources (1)

  • FDA UDI e56cd3f1-fed1-48b2-aaa3-ff51637e95e3 37 fields · synced May 30, 2026