INSTI HIV-1/HIV-2 Control Test 90-1031

GUDID 06865979010313

INSTI HIV-1/HIV-2 Control Test

BioLytical Laboratories Inc

HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid

Primary Device ID	06865979010313
NIH Device Record Key	4a5d0664-ec5e-4e7b-a71d-ba14cc2466b3
Commercial Distribution Status	In Commercial Distribution
Brand Name	INSTI HIV-1/HIV-2 Control Test
Version Model Number	90-1031
Catalog Number	90-1031
Company DUNS	201060071
Company Name	BioLytical Laboratories Inc
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Operating and Storage Conditions

Storage Environment Temperature	Between -20 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	06865979010313 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

BP090032

FDA Product Code

MZF	Test, Hiv Detection

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2016-01-05

Devices Manufactured by BioLytical Laboratories Inc

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00686597010310 - INSTI HIV-1/HIV-2 Control Test Kit	2020-10-08 INSTI HIV-1/HIV-2 Control Test Kit
06865978010376 - INSTI HIV-1/HIV-2 Test Controls	2018-07-06 INSTI HIV-1/HIV-2 Test Controls
06865978010710 - INSTI Test Controls HIV-1	2018-07-06 INSTI Test Controls HIV-1
06865979010184 - INSTI HIV-1/HIV-2 Antibody Test	2018-07-06 24 Tests with support materials
06865979010191 - INSTI HIV-1/HIV-2 Antibody Test	2018-07-06 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 Test	2018-07-06 24 tests without support material