DEVICE: NeoGram Derivatized Assay Solutions (06438147283842)

Device Identifier (DI) Information

NeoGram Derivatized Assay Solutions
3030-0020
In Commercial Distribution
3030-0020
Wallac Oy
06438147283842
GS1

1
540156544 *Terms of Use
The product is to be used together with the NeoGram Amino Acids and Acylcarnitines Tandem Mass Spectrometry kit, and is intended for the measurement of amino acid, free carnitine, and acylcarnitine concentrations from newborn heel prick blood samples dried on filter paper.
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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.
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FDA Product Code

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

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

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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Temperature: between 2 and 30 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

942d8fcf-a3cc-431c-b8e1-ae801d719cc2
July 06, 2018
3
February 11, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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None
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Production Identifier(s) in UDI

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Customer Contact

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No Customer Contact currently defined
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