INTROL CF Panel I Control G106ac

GUDID 00852720008015

This independent CF control is intended for in vitro diagnostic use to monitor the entire testing process of diagnostic assays used in the detection of the CFTR gene mutations and variants.

Mmqci

Cystic fibrosis IVD, control
Primary Device ID00852720008015
NIH Device Record Key658d32f2-0d9a-426b-b834-073300a3cd2e
Commercial Distribution StatusIn Commercial Distribution
Brand NameINTROL CF Panel I Control
Version Model Numberv.02
Catalog NumberG106ac
Company DUNS172874245
Company NameMmqci
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
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

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Opened material returned to the refrigerator (2° – 8°C) shortly after use is stable for thirty (30) days from the date of opening.

Device Identifiers

Device Issuing AgencyDevice ID
GS100852720008015 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NZBQuality Control Material, Genetics, Dna

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-01-01
Device Publish Date2019-12-24

On-Brand Devices [INTROL CF Panel I Control]

00852720008008This independent CF control is intended for in vitro diagnostic use to monitor the entire testin
00852720008015This independent CF control is intended for in vitro diagnostic use to monitor the entire testin

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