AccessGUDID - DEVICE: Xpert BCR-ABL IS p210 Linearity Panel C207 (00852720008183)

GUDID

Device Identifier (DI) Information

Brand Name: Xpert BCR-ABL IS p210 Linearity Panel C207
Version or Model: v.00
Commercial Distribution Status: In Commercial Distribution
Catalog Number: C207
Company Name: Mmqci

Primary DI Number: 00852720008183
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 172874245 *Terms of Use

Device Description: Reference material to monitor the performance of the in vitro quantitative detection of BCR-ABL1 and ABL1 mRNA transcripts for Xpert BCR-ABL Ultra assay on the Cepheid GeneXpert system.

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):	No
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?
47960	Philadelphia chromosome/BCR-ABL transcript IVD, control	A material which is used to verify the performance of an assay intended to be used to evaluate a clinical specimen to diagnose, monitor or predict chronic myeloid leukaemia (CML) or a subset of acute lymphoblastic leukaemia (ALL) associated with the Philadelphia chromosome, resulting from translocation t(9;22)(q34;q11) and rearrangement of the BCR and ABL genes.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QIG	Quality Control Material, Genetics, Rna

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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 -25 and -15 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4c7afa54-6bac-4363-a805-9a164e9c4441
Public Version Date: September 25, 2023
Public Version Number: 1
DI Record Publish Date: September 15, 2023