Xpert BCR-ABL IS Panel C130 C130

GUDID 00852720008060

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.

Mmqci

Philadelphia chromosome/BCR-ABL transcript IVD, control

• Primary Device ID: 00852720008060
• NIH Device Record Key: e2cfee70-3396-4da0-9566-66d866e390a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Xpert BCR-ABL IS Panel C130
• Version Model Number: v.00
• Catalog Number: C130
• Company DUNS: 172874245
• Company Name: Mmqci
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 207-885-1072
• Email: info@mmqci.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852720008060 [Primary]

FDA Product Code

• QIG: Quality Control Material, Genetics, Rna

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-12
• Device Publish Date: 2019-12-04

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