FDA.reportPublic FDA data

INSTI HIV-1 Control Test Kit

Primary DI
00686597010303
Brand
INSTI HIV-1 Control Test Kit
Company
Biolytical Laboratories Inc
Model
90-1030
Catalog number
90-1030
Device description
INSTI HIV-1 Control Test Kit
Published
2020-09-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
MZFTest, Hiv Detection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MZFTest, Hiv DetectionMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BP09003211

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BP09003211

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00686597010303PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00686597010303006865970103036865970103030686597010303

GMDN Terms#

Term, Definition table
TermDefinition
HIV1/HIV2 antibody IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of antibodies to human immunodeficiency virus 1 and 2 (HIV1/HIV2) in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-20 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
201060071
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00686597201725INSTI HIV Self Test90-107390-10732025-11-19
06865978010376INSTI HIV-1/HIV-2 Test Controls80-103780-10372015-08-21
06865978010710INSTI Test Controls HIV-1 80-107180-10712015-08-21
06865979010184INSTI HIV-1/HIV-2 Antibody TestWith Support90-10182015-02-25
06865979010191INSTI HIV-1/HIV-2 Antibody TestSingle90-10192015-02-25
06865979010207INSTI HIV-1/HIV-2 Antibody TestWithout Support90-10202015-02-25
00686597010198INSTI HIV-1/HIV-2 Antibody Test90-101990-10192020-09-30
00686597010310INSTI HIV-1/HIV-2 Control Test Kit90-103190-10312020-09-30
06865979010306HIV-1 Control Test Kit90-103090-10302016-01-05
06865979010313INSTI HIV-1/HIV-2 Control Test90-103190-10312016-01-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00875197006384cobas® HIV-1/HIV-2 QualitativeRoche Molecular Systems, Inc.MZF2025-03-31
00608337001792OraQuick HIV Self-TestOrasure Technologies, Inc.MZF2024-09-05
00608337001808OraQuick HIV Self-TestOrasure Technologies, Inc.MZF2024-09-05
00628451188186Reveal G4 Rapid HIV-1/2 Antibody TestMedMira Laboratories IncMZF2024-04-11
00628451188193Reveal G4 Rapid HIV-1/2 Antibody TestMedMira Laboratories IncMZF2024-04-11
00628451188209HIV-1/2 Antibody Test ControlsMedMira Laboratories IncMZF2024-04-11
10628451188213HIV-1/2 Antibody Test ControlsMedMira Laboratories IncMZF2024-04-11
10628451188220Reveal G4 Rapid HIV-1/2 Antibody TestMedMira Laboratories IncMZF2024-04-11
10628451188237Reveal G4 Rapid HIV-1/2 Antibody TestMedMira Laboratories IncMZF2024-04-11
10628451188244Reveal G4 Rapid HIV-1/2 Antibody TestMedMira Laboratories IncMZF2024-04-11
10628451188251HIV-1/2 Antibody Test ControlsMedMira Laboratories IncMZF2024-04-11
10628451188268HIV-1/2 Antibody Test ControlsMedMira Laboratories IncMZF2024-04-11
00628451188179Reveal G4 Rapid HIV-1/2 Antibody TestMedMira Laboratories IncMZF2024-04-10
10628451188169Reveal G4 Rapid HIV-1/2 Antibody TestMedMira Laboratories IncMZF2024-04-08
15099590745158ACCESS HIV Ag/Ab comboBeckman Coulter, Inc.MZF2024-03-15
00884999050853Alinity mABBOTT MOLECULAR INC.MZF2023-06-08
07613336215845Elecsys HIV DuoRoche Diagnostics GmbHMZF2022-09-22
00884999050402Alinity mABBOTT MOLECULAR INC.MZF2022-08-29
00875197006445cobas® NHP Negative Control KitRoche Molecular Systems, Inc.MZF2022-08-01
00811877011101Determine™ HIV–1/2 Ag/Ab Combo Alere Scarborough, Inc.MZF2022-01-13
00811877011125Determine™ HIV–1/2 Ag/Ab Combo Controls Alere Scarborough, Inc.MZF2022-01-13
00875197006483cobas HIV-1/HIV-2 Qualitative Control KitRoche Molecular Systems, Inc.MZF2021-12-14
00875197006407cobas® HIV-1Roche Molecular Systems, Inc.MZF2021-12-10
00875197006476cobas® HBV/HCV/HIV-1 Control KitRoche Molecular Systems, Inc.MZF2021-12-10
07613336170182Elecsys HIV combi PTRoche Diagnostics GmbHMZF2021-09-16
07613336170212Elecsys HIV combi PTRoche Diagnostics GmbHMZF2021-09-16
00630414301280Atellica IM CHIVSiemens Healthcare Diagnostics Inc.MZF2021-01-15
00607158000083DPP HIV-SyphilisChembio Diagnostic Systems Inc.MZF2020-12-29
00686597010198INSTI HIV-1/HIV-2 Antibody TestBiolytical Laboratories IncMZF2020-09-30
00686597010310INSTI HIV-1/HIV-2 Control Test KitBiolytical Laboratories IncMZF2020-09-30