INSTI Test Controls HIV-1 80-1071

GUDID 06865978010710

INSTI Test Controls HIV-1

BioLytical Laboratories Inc

HIV1/HIV2 antigen IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID06865978010710
NIH Device Record Keybed6ea12-51de-41fa-9d6a-7b39bbf3beeb
Commercial Distribution Discontinuation2016-07-01
Commercial Distribution StatusNot in Commercial Distribution
Brand NameINSTI Test Controls HIV-1
Version Model Number80-1071
Catalog Number80-1071
Company DUNS201060071
Company NameBioLytical Laboratories Inc
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
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

Operating and Storage Conditions

Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween -70 Degrees Celsius and -20 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween -70 Degrees Celsius and -20 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween -70 Degrees Celsius and -20 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween -70 Degrees Celsius and -20 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween -70 Degrees Celsius and -20 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween -70 Degrees Celsius and -20 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween -70 Degrees Celsius and -20 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween -70 Degrees Celsius and -20 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween -70 Degrees Celsius and -20 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween -70 Degrees Celsius and -20 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween -70 Degrees Celsius and -20 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween -70 Degrees Celsius and -20 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween -70 Degrees Celsius and -20 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween -70 Degrees Celsius and -20 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween -70 Degrees Celsius and -20 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween -70 Degrees Celsius and -20 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween -70 Degrees Celsius and -20 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween -70 Degrees Celsius and -20 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween -70 Degrees Celsius and -20 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween -70 Degrees Celsius and -20 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween -70 Degrees Celsius and -20 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween -70 Degrees Celsius and -20 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween -70 Degrees Celsius and -20 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS106865978010710 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MZFTest, Hiv Detection

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-08-21

Devices Manufactured by BioLytical Laboratories Inc

00686597010198 - INSTI HIV-1/HIV-2 Antibody Test2020-10-08 Single-use rapid assay for the detection of antibodies to Human Immunodeficiency Virus Type 1 and Type 2 (HIV-1, HIV-2)
00686597010303 - INSTI HIV-1 Control Test Kit2020-10-08 INSTI HIV-1 Control Test Kit
00686597010310 - INSTI HIV-1/HIV-2 Control Test Kit2020-10-08 INSTI HIV-1/HIV-2 Control Test Kit
06865978010376 - INSTI HIV-1/HIV-2 Test Controls2018-07-06 INSTI HIV-1/HIV-2 Test Controls
06865978010710 - INSTI Test Controls HIV-1 2018-07-06INSTI Test Controls HIV-1
06865978010710 - INSTI Test Controls HIV-1 2018-07-06 INSTI Test Controls HIV-1
06865979010184 - INSTI HIV-1/HIV-2 Antibody Test2018-07-06 24 Tests with support materials
06865979010191 - INSTI HIV-1/HIV-2 Antibody Test2018-07-06 Single-use rapid assay for the detection of antibodies to Human Immunodeficiency Virus Type 1 and Type 2 (HIV-1, HIV-2)
06865979010207 - INSTI HIV-1/HIV-2 Antibody Test2018-07-06 24 tests without support material

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