Alinity m 09N61-085

GUDID 00884999050587

Alinity m HSV 1 & 2 / VZV CTRL Kit

ABBOTT MOLECULAR INC.

Multiple Human herpesvirus nucleic acid IVD, control
Primary Device ID00884999050587
NIH Device Record Key3237a363-95d5-45aa-9db4-6495aac09a89
Commercial Distribution StatusIn Commercial Distribution
Brand NameAlinity m
Version Model Number09N61-085
Catalog Number09N61-085
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 Perscriptiontrue
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
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
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
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
GS100884999050587 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PGIHerpes virus (VZV, HSV1, HSV2), DNA detection assay for cutaneous and mucocutaneous lesion samples

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-08-05
Device Publish Date2024-07-26

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00884999047464Alinity m Universal Sample Rack
00884999047457Alinity m Handheld Barcode Scanner
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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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0088499904778508N45-085
0088499904777808N45-075
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00884999047815Alinity m HBV CTRL Kit
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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
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3088499905041009N19-012
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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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