DEVICE: NeoBase Succinylacetone Assay Solution (06438147295708)

Device Identifier (DI) Information

NeoBase Succinylacetone Assay Solution
3042-0020
In Commercial Distribution
3042-0020
Wallac Oy
06438147295708
GS1

1
540156544 *Terms of Use
The NeoBase™ Succinylacetone Assay Solution is intended for in vitro diagnostic use with the NeoBase Non-derivatized MSMS Kit and the NeoBase non-derivatized Assay Solutions. The NeoBase™ Succinylacetone Assay Solution is used for the measurement and evaluation of succinylacetone concentration from blood samples dried on filter paper (DBS).
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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 [?]
K083130 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 8 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

312a0807-2d2d-4315-8b69-c7f534ac573d
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
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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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