Xpert BCR-ABL IS p210 Linearity Panel C207 C207

GUDID 00852720008183

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 ID00852720008183
NIH Device Record Key4c7afa54-6bac-4363-a805-9a164e9c4441
Commercial Distribution StatusIn Commercial Distribution
Brand NameXpert BCR-ABL IS p210 Linearity Panel C207
Version Model Numberv.00
Catalog NumberC207
Company DUNS172874245
Company NameMmqci
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone207-885-1072
Emailinfo@mmqci.com
Phone207-885-1072
Emailinfo@mmqci.com
Phone207-885-1072
Emailinfo@mmqci.com
Phone207-885-1072
Emailinfo@mmqci.com
Phone207-885-1072
Emailinfo@mmqci.com
Phone207-885-1072
Emailinfo@mmqci.com
Phone207-885-1072
Emailinfo@mmqci.com
Phone207-885-1072
Emailinfo@mmqci.com
Phone207-885-1072
Emailinfo@mmqci.com
Phone207-885-1072
Emailinfo@mmqci.com
Phone207-885-1072
Emailinfo@mmqci.com
Phone207-885-1072
Emailinfo@mmqci.com
Phone207-885-1072
Emailinfo@mmqci.com
Phone207-885-1072
Emailinfo@mmqci.com
Phone207-885-1072
Emailinfo@mmqci.com
Phone207-885-1072
Emailinfo@mmqci.com
Phone207-885-1072
Emailinfo@mmqci.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100852720008183 [Primary]

FDA Product Code

QIGQuality Control Material, Genetics, Rna

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-25
Device Publish Date2023-09-15

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00852720008183 - Xpert BCR-ABL IS p210 Linearity Panel C2072023-09-25Reference 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.
00852720008183 - Xpert BCR-ABL IS p210 Linearity Panel C2072023-09-25 Reference material to monitor the performance of the in vitro quantitative detection of BCR-ABL1 and ABL1 mRNA transcripts for X
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