Alinity m 09N78-085

GUDID 00884999049208

Alinity m SARS-CoV-2 CTRL Kit

ABBOTT MOLECULAR INC.

SARS-CoV-2 nucleic acid IVD, control
Primary Device ID00884999049208
NIH Device Record Key35ce88f7-71c0-40f4-bf59-d6fb97942785
Commercial Distribution StatusIn Commercial Distribution
Brand NameAlinity m
Version Model Number09N78-085
Catalog Number09N78-085
Company DUNS878263359
Company NameABBOTT MOLECULAR INC.
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100884999049208 [Primary]

FDA Product Code

QJRReagents, 2019-novel coronavirus nucleic acid

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-15
Device Publish Date2020-05-07

On-Brand Devices [Alinity m]

00884999048171Alinity m IRU Waste Container
00884999048096Alinity m Sample Rack Holder
20884999047864Alinity m Integrated Reaction Unit (IRU)
20884999047857Alinity m Pipette Tips, 1000uL
20884999047840Allinity m Pipette Tips, 50uL
00884999047501Alinity m CO-RE Tip Sleeve
00884999047488Alinity m Pipette Tip Adapters
00884999047464Alinity m Universal Sample Rack
00884999047457Alinity m Handheld Barcode Scanner
00884999047440Alinity m Assay Tray Carrier
00884999047433Alinity m Waste Bottle
00884999047426Alinity m Waste Box
00884999048652Alinity m HCV Application Specification File
00884999047839Alinity m HCV CTRL Kit
00884999047822Alinity m HCV CAL Kit
00884999047761Alinity m HCV AMP Kit
00884999049222Alinity m SARS-CoV-2 AMP Kit
00884999049208Alinity m SARS-CoV-2 CTRL Kit
00884999049185Alinity m SARS-CoV-2 Application Specification File
20884999047901Alinity m Diluent Solution Kit
00884999047716Alinity m Vapor Barrier Solution
00884999048034Alinity m System
0088499904773008N45-095
00884999048638Alinity m HIV-1 Application Specification File
0088499904778508N45-085
0088499904777808N45-075
00884999048645Alinity m HBV Application Specification File
00884999047815Alinity m HBV CTRL Kit
00884999047808Alinity m HBV CAL Kit
00884999047754Alinity m HBV AMP Kit
00884999049413Alinity m Resp-4-Plex Application Specification File
00884999049406Alinity m Resp-4-Plex CTRL Kit
00884999049390Alinity m Resp-4-Plex AMP Kit
008849990500201.00
00884999050136Alinity m SARS COV-2 Application Specification File
00884999050211Alinity m SARS-CoV-2 Application Specification
00884999047877Alinity m Lysis Solution
00884999047679Alinity m Sample Prep Kit 2
00884999049314Alinity m Bottle for Ethanol Use
3088499905041009N19-012
00884999047693Alinity m Ethanol Solution
00884999047686Alinity m Sample Prep Kit 1
00884999050280Abbott Bulk Universal Collection Kit
00884999049956Alinity m CMV Application Specification File
00884999049611Alinity m CMV AMP Kit
00884999049604Alinity m CMV CTRL Kit
00884999049598Alinity m CMV CAL Kit
00884999048669Alinity m STI Application Specification File
00884999048607Alinity m STI CTRL Kit
00884999048591Alinity m STI AMP Kit
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.