DEVICE: EnLite Neonatal TREC kit (06438147331802)

Device Identifier (DI) Information

EnLite Neonatal TREC kit
3401-001U
In Commercial Distribution
3401-001U
Wallac Oy
06438147331802
GS1

1
540156544 *Terms of Use
Polymerase chain reaction (PCR) based assay for semiquantitative determination of TREC DNA in dried blood specimens.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
Yes
No
No

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
T-cell receptor excision circle (TREC) IVD, kit, nucleic acid technique (NAT) A collection of reagents and other associated materials intended to be used for the quantitative measurement of T-cell receptor excision circles, or circular remnants of deoxyribonucleic acid (DNA) formed during normal T-cell development, in a clinical specimen using a nucleic acid technique (NAT).
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FDA Product Code

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Product Code Product Code Name
PJI Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
DEN140010 000
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Sterilization

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

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Storage and Handling
Storage Environment Temperature: between -30 and -16 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

558bfbeb-a479-41e4-a083-bc08323f596a
July 06, 2018
3
February 02, 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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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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