Alinity m 09N46-075

GUDID 00884999049598

Alinity m CMV CAL Kit

ABBOTT MOLECULAR INC.

Cytomegalovirus (CMV) nucleic acid IVD, calibrator
Primary Device ID00884999049598
NIH Device Record Key28db1177-e9bb-481b-807d-cb217ada3f2a
Commercial Distribution StatusIn Commercial Distribution
Brand NameAlinity m
Version Model Number09N46-075
Catalog Number09N46-075
Company DUNS878263359
Company NameABBOTT MOLECULAR INC.
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 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

Phone+1(800)553-7042
Emailcustomerservice@abbottmolecular.com
Phone+1(800)553-7042
Emailcustomerservice@abbottmolecular.com
Phone+1(800)553-7042
Emailcustomerservice@abbottmolecular.com
Phone+1(800)553-7042
Emailcustomerservice@abbottmolecular.com
Phone+1(800)553-7042
Emailcustomerservice@abbottmolecular.com
Phone+1(800)553-7042
Emailcustomerservice@abbottmolecular.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

Device Identifiers

Device Issuing AgencyDevice ID
GS100884999049598 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PABCytomegalovirus (cmv) dna quantitative assay

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-27
Device Publish Date2022-05-19

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