DEVICE: TruSight™ Cystic Fibrosis Library Preparation (00816270020149)

Device Identifier (DI) Information

TruSight™ Cystic Fibrosis Library Preparation
20036925
Not in Commercial Distribution
20036925
ILLUMINA, INC.
00816270020149
GS1
April 09, 2020
1
033305264 *Terms of Use
The TruSight™ Cystic Fibrosis Library Prep is a library preparation kit that supports the TruSight Cystic Fibrosis 139 Variant Assay and the TruSight Cystic Fibrosis Clinical Sequencing Assay. The TruSight Cystic Fibrosis Library Preparation is an IVD kit consisting of the individual boxes listed below, which are all labeled with the same Device Identifier: 20035690, TruSight™ Cystic Fibrosis Library Prep, 1/3; 20035693, TruSight™ Cystic Fibrosis Library Prep, 2/3; 20035694, TruSight™ Cystic Fibrosis Library Prep, 3/3.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
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GMDN

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GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
62604 Nucleic acid library construction kit IVD
A collection of reagents and other associated materials intended to be used for the construction of fragmented nucleic acids [deoxyribonucleic acid (DNA) or ribonucleic acid (RNA)] for use in genomic sequencing assays. It typically consists of buffers, primers, enzymes (e.g., DNA polymerase, DNA ligase) and deoxynucleotides (dNTPs) and is intended to be used for whole genome and/or complementary deoxyribonucleic acid (cDNA) library construction.
Active false
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FDA Product Code

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Product Code Product Code Name
PFT Reagents For Molecular Diagnostic Test Systems
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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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 -25 and -15 Degrees Celsius
Storage Environment Temperature: between 2 and 8 Degrees Celsius
Storage Environment Temperature: between 15 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

5234fc51-bcdc-41f4-ba5b-ca8f217e255a
July 11, 2023
2
April 09, 2020
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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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Customer Contact

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No Customer Contact currently defined
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