Alinity m 09N17-085

GUDID 00884999048607

Alinity m STI CTRL Kit

ABBOTT MOLECULAR INC.

Multiple-type sexually transmitted pathogen nucleic acid IVD, control
Primary Device ID00884999048607
NIH Device Record Key85794129-8ecc-4cba-9e4e-1a8c0055baee
Commercial Distribution StatusIn Commercial Distribution
Brand NameAlinity m
Version Model Number09N17-085
Catalog Number09N17-085
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
GS100884999048607 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QEPNucleic acid detection system for non-viral microorganism(s) causing sexually transmitted infections

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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20884999047840Allinity m Pipette Tips, 50uL
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00884999047464Alinity m Universal Sample Rack
00884999047457Alinity m Handheld Barcode Scanner
00884999047440Alinity m Assay Tray Carrier
00884999047433Alinity m Waste Bottle
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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
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0088499904773008N45-095
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0088499904777808N45-075
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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
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