AccessGUDID - DEVICE: NeoGram Amino Acids and Acylcarnitines Tandem Mass Spectrometry Kit (06438147283835)

GUDID

Device Identifier (DI) Information

Brand Name: NeoGram Amino Acids and Acylcarnitines Tandem Mass Spectrometry Kit
Version or Model: 3026-0030
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 3026-0030
Company Name: Wallac Oy

Primary DI Number: 06438147283835
Issuing Agency: GS1
Commercial Distribution End Date: March 18, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 540156544 *Terms of Use

Device Description: For the quantitative determination of amino acid, acylcarnitine and free carnitine concentrations in dried blood.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
58190	Multiple amino acid/carnitine metabolite IVD, kit, mass spectrometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of multiple amino acids, nucleosides, lysophospholipids, and/or carnitine metabolites associated with metabolic disorders of a newborn in a clinical specimen, using a mass spectrometry method. Analytes detected may include all amino acids, free carnitine, acylcarnitine, succinylacetone, adenosine and/or lysophosphatidylcholine.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NQL	System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN040002	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e56cd3f1-fed1-48b2-aaa3-ff51637e95e3
Public Version Date: March 30, 2022
Public Version Number: 4
DI Record Publish Date: January 12, 2016