AccessGUDID - DEVICE: MiSeqDx Universal Kit 1.0 (00816270020040)

GUDID

Device Identifier (DI) Information

Brand Name: MiSeqDx Universal Kit 1.0
Version or Model: 15038741
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: DX-103-1001
Company Name: ILLUMINA, INC.

Primary DI Number: 00816270020040
Issuing Agency: GS1
Commercial Distribution End Date: August 10, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 033305264 *Terms of Use

Device Description: The MiSeqDx Universal Kit 1.0 is a set of reagents and consumables used in the processing of human genomic DNA samples derived from peripheral whole blood, and in the subsequent targeted re-sequencing of the resulting sample libraries. User-supplied analyte specific reagents are required for the preparation of libraries targeting specific genomic regions of interest. MiSeqDx Universal Kit 1.0 (2 Run) is an IVD kit consisting of the individual boxes listed below which are all labeled with the same Device Identifier: 15039490 MiSeqDx Universal Kit 1.0 1/5 15039485 MiSeqDx Universal Kit 1.0 1A 15039488 MiSeqDx Universal Kit 1.0 1B 15039492 MiSeqDx Universal Kit 1.0 2/5 15039498 MiSeqDx Universal Kit 1.0 3/5 15039494 MiSeqDx Universal Kit 1.0 3A 15039496 MiSeqDx Universal Kit 1.0 3B 15039500 MiSeqDx Universal Kit 1.0 4/5 15039503 MiSeqDx Universal Kit 1.0 5/5

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:	Yes
Prescription Use (Rx):	Yes
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?
62173	Nucleic acid sequencing reagent kit IVD	A collection of reagents and other associated materials intended to be used on-board a nucleic acid sequencing instrument for the genetic analysis of a clinical specimen. It typically consists of buffers, primers, enzymes (e.g., DNA polymerase, DNA ligase) and deoxynucleotides (dNTPs). It does not contain analyte-specific reagents and is not intended to be used for whole genome or complementary deoxyribonucleic acid (cDNA) library construction.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PFT	Reagents For Molecular Diagnostic Test Systems

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN130042	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 15 and 30 Degrees Celsius
Storage Environment Temperature: between 15 and 25 Degrees Celsius
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: fddb1e32-cea9-417b-90ca-23def8d73a3c
Public Version Date: August 11, 2020
Public Version Number: 4
DI Record Publish Date: September 21, 2016