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52 device results listed.

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INSTI Multiplex HIV-1/2 Syphilis Ab Test

90-1028-021 and 90-1028-022

IVD Annex II List AIVDDOn the marketKitNear-patient testingProfessional testingSingle use

Manufacturer: bioLytical Laboratories Inc.
Manufacturer SRN: CA-MF-000023304
UDI-DI: 00686597202265
Basic UDI-DI: B-00686597202265
Reference: 90-1028-021 and 90-1028-022
EMDN: W0105010302
EMDN description: SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 04.07.2026 18:04

Manufacturer products Authorised representative products Authorised representative actors View details

INSTI HIV-1/HIV-2 ANTIBODY TEST KIT

90-1015-017 and 90-1015-018

IVD Annex II List AIVDDOn the marketKitNear-patient testingProfessional testingSingle use

Manufacturer: bioLytical Laboratories Inc.
Manufacturer SRN: CA-MF-000023304
UDI-DI: 00686597202173
Basic UDI-DI: B-00686597202173
Reference: 90-1015-017 and 90-1015-018
EMDN: W0105030402
EMDN description: HIV MULTIPLE ANTIBODY
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 04.07.2026 18:04

Manufacturer products Authorised representative products Authorised representative actors View details

INSTI T. pallidum Test Controls

90-1032

IVD Annex II List AIVDDOn the marketKitNear-patient testingProfessional testing

Manufacturer: bioLytical Laboratories Inc.
Manufacturer SRN: CA-MF-000023304
UDI-DI: 00686597202128
Basic UDI-DI: B-00686597202128
Reference: 90-1032
EMDN: W0105094001
EMDN description: CONTROLS INFECTIOUS IMMUNOLOGY - RT & POC
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 04.07.2026 18:04

Manufacturer products Authorised representative products Authorised representative actors View details

INSTI HIV-1/HIV-2 ANTIBODY TEST

90-1015-015 and 90-1015-016

IVD Annex II List AIVDDOn the marketKitNear-patient testingProfessional testingSingle use

Manufacturer: bioLytical Laboratories Inc.
Manufacturer SRN: CA-MF-000023304
UDI-DI: 00686597202067
Basic UDI-DI: B-00686597202067
Reference: 90-1015-015 and 90-1015-016
EMDN: W0105030402
EMDN description: HIV MULTIPLE ANTIBODY
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 04.07.2026 18:04

Manufacturer products Authorised representative products Authorised representative actors View details

48 INSTI HIV-1/HIV-2 ANTIBODY TEST

90-1026-001

IVD Annex II List AIVDDOn the marketKitNear-patient testingProfessional testingSingle use

Manufacturer: bioLytical Laboratories Inc.
Manufacturer SRN: CA-MF-000023304
UDI-DI: 00686597201947
Basic UDI-DI: B-00686597201947
Reference: 90-1026-001
EMDN: W0105030402
EMDN description: HIV MULTIPLE ANTIBODY
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 04.07.2026 18:04

Manufacturer products Authorised representative products Authorised representative actors View details

INSTI Multiplex HIV-1/2 Syphilis Ab Test

90-1028-019 and 90-1028-020

IVD Annex II List AIVDDOn the marketKitProfessional testingSelf testingSingle use

Manufacturer: bioLytical Laboratories Inc.
Manufacturer SRN: CA-MF-000023304
UDI-DI: 00686597201831
Basic UDI-DI: B-00686597201831
Reference: 90-1028-019 and 90-1028-020
EMDN: W0105030402
EMDN description: HIV MULTIPLE ANTIBODY
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 04.07.2026 18:04

Manufacturer products Authorised representative products Authorised representative actors View details

48 INSTI HIV-1/HIV-2 ANTIBODY TEST

90-1026-002

IVD Annex II List AIVDDOn the marketKitNear-patient testingProfessional testingSingle use

Manufacturer: bioLytical Laboratories Inc.
Manufacturer SRN: CA-MF-000023304
UDI-DI: 00686597201824
Basic UDI-DI: B-00686597201824
Reference: 90-1026-002
EMDN: W0105030402
EMDN description: HIV MULTIPLE ANTIBODY
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 04.07.2026 18:04

Manufacturer products Authorised representative products Authorised representative actors View details

INSTI HIV Self Test (no pipette variant, packaged in a pouch)

90-1041-014 and 90-1041-015

IVD Annex II List AIVDDOn the marketKitSelf testingSingle use

Manufacturer: bioLytical Laboratories Inc.
Manufacturer SRN: CA-MF-000023304
UDI-DI: 00686597201794
Basic UDI-DI: B-00686597201794
Reference: 90-1041-014 and 90-1041-015
EMDN: W0105030402
EMDN description: HIV MULTIPLE ANTIBODY
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 04.07.2026 18:04

Manufacturer products Authorised representative products Authorised representative actors View details

INSTI HIV Self Test (no pipette variant, packaged in pouch)

90-1041-012 and 90-1041-013

IVD Annex II List AIVDDOn the marketKitSelf testingSingle use

Manufacturer: bioLytical Laboratories Inc.
Manufacturer SRN: CA-MF-000023304
UDI-DI: 00686597201770
Basic UDI-DI: B-00686597201770
Reference: 90-1041-012 and 90-1041-013
EMDN: W0105030402
EMDN description: HIV MULTIPLE ANTIBODY
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 04.07.2026 18:04

Manufacturer products Authorised representative products Authorised representative actors View details

48 INSTI HIV-1/HIV-2 ANTIBODY TEST

90-1026-003

IVD Annex II List AIVDDOn the marketKitNear-patient testingProfessional testingSingle use

Manufacturer: bioLytical Laboratories Inc.
Manufacturer SRN: CA-MF-000023304
UDI-DI: 00686597201763
Basic UDI-DI: B-00686597201763
Reference: 90-1026-003
EMDN: W0105030402
EMDN description: HIV MULTIPLE ANTIBODY
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 04.07.2026 18:04

Manufacturer products Authorised representative products Authorised representative actors View details

INSTI HIV-1/HIV-2 ANTIBODY TEST

90-1015-013 and 90-1015-014

IVD Annex II List AIVDDOn the marketKitNear-patient testingProfessional testingSingle use

Manufacturer: bioLytical Laboratories Inc.
Manufacturer SRN: CA-MF-000023304
UDI-DI: 00686597201664
Basic UDI-DI: B-00686597201664
Reference: 90-1015-013 and 90-1015-014
EMDN: W0105030402
EMDN description: HIV MULTIPLE ANTIBODY
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 04.07.2026 18:04

Manufacturer products Authorised representative products Authorised representative actors View details

INSTI Multiplex HIV-1/2 Syphilis Ab Test

90-1028-015 and 90-1028-016

IVD Annex II List AIVDDOn the marketKitNear-patient testingProfessional testingSingle use

Manufacturer: bioLytical Laboratories Inc.
Manufacturer SRN: CA-MF-000023304
UDI-DI: 00686597201640
Basic UDI-DI: B-00686597201640
Reference: 90-1028-015 and 90-1028-016
EMDN: W0105010302
EMDN description: SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 04.07.2026 18:04

Manufacturer products Authorised representative products Authorised representative actors View details

INSTI Multiplex HIV-1/2 Syphilis Ab Test

90-1028-017 and 90-1028-018

IVD Annex II List AIVDDOn the marketKitNear-patient testingProfessional testingSingle use

Manufacturer: bioLytical Laboratories Inc.
Manufacturer SRN: CA-MF-000023304
UDI-DI: 00686597201619
Basic UDI-DI: B-00686597201619
Reference: 90-1028-017 and 90-1028-018
EMDN: W0105010302
EMDN description: SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 04.07.2026 18:04

Manufacturer products Authorised representative products Authorised representative actors View details

INSTI HIV ANTIBODY SELF-TEST

90-1060-001, 90-1060-002, 90-1060-003, and 90-1060-004

IVD Annex II List AIVDDOn the marketKitSelf testingSingle use

Manufacturer: bioLytical Laboratories Inc.
Manufacturer SRN: CA-MF-000023304
UDI-DI: 00686597201466
Basic UDI-DI: B-00686597201466
Reference: 90-1060-001, 90-1060-002, 90-1060-003 and 90-1060-004
EMDN: W0105030402
EMDN description: HIV MULTIPLE ANTIBODY
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 04.07.2026 18:04

Manufacturer products Authorised representative products Authorised representative actors View details

INSTI HIV ANTIBODY SELF-TEST

90-1076-005 and 90-1076-006

IVD Annex II List AIVDDOn the marketKitSelf testingSingle use

Manufacturer: bioLytical Laboratories Inc.
Manufacturer SRN: CA-MF-000023304
UDI-DI: 00686597201428
Basic UDI-DI: B-00686597201428
Reference: 90-1076-005 and 90-1076-006
EMDN: W0105030402
EMDN description: HIV MULTIPLE ANTIBODY
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 04.07.2026 18:04

Manufacturer products Authorised representative products Authorised representative actors View details

INSTI HIV ANTIBODY SELF-TEST

90-1076-003 and 90-1076-004

IVD Annex II List AIVDDOn the marketKitSelf testingSingle use

Manufacturer: bioLytical Laboratories Inc.
Manufacturer SRN: CA-MF-000023304
UDI-DI: 00686597201404
Basic UDI-DI: B-00686597201404
Reference: 90-1076-003 and 90-1076-004
EMDN: W0105030402
EMDN description: HIV MULTIPLE ANTIBODY
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 04.07.2026 18:04

Manufacturer products Authorised representative products Authorised representative actors View details

INSTI Multiplex HIV-1/2 Syphilis Ab Test

90-1028-013 and 90-1028-014

IVD Annex II List AIVDDOn the marketKitNear-patient testingProfessional testingSingle use

Manufacturer: bioLytical Laboratories Inc.
Manufacturer SRN: CA-MF-000023304
UDI-DI: 00686597201336
Basic UDI-DI: B-00686597201336
Reference: 90-1028-013 and 90-1028-014
EMDN: W0105010302
EMDN description: SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 04.07.2026 18:04

Manufacturer products Authorised representative products Authorised representative actors View details

INSTI HIV ANTIBODY SELF-TEST

90-1126-001 and 90-1126-002

IVD Annex II List AIVDDOn the marketKitSelf testingSingle use

Manufacturer: bioLytical Laboratories Inc.
Manufacturer SRN: CA-MF-000023304
UDI-DI: 00686597201244
Basic UDI-DI: B-00686597201244
Reference: 90-1126-001 and 90-1126-002
EMDN: W0105030402
EMDN description: HIV MULTIPLE ANTIBODY
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 04.07.2026 18:04

Manufacturer products Authorised representative products Authorised representative actors View details

INSTI HIV ANTIBODY SELF-TEST

90-1123-001

IVD Annex II List AIVDDOn the marketKitSelf testingSingle use

Manufacturer: bioLytical Laboratories Inc.
Manufacturer SRN: CA-MF-000023304
UDI-DI: 00686597200889
Basic UDI-DI: B-00686597200889
Reference: 90-1123-001
EMDN: W0105030402
EMDN description: HIV MULTIPLE ANTIBODY
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 04.07.2026 18:04

Manufacturer products Authorised representative products Authorised representative actors View details

INSTI HIV-1/HIV-2 ANTIBODY TEST KIT

90-1026

IVD Annex II List AIVDDOn the marketKitProfessional testingSingle use

Manufacturer: bioLytical Laboratories Inc.
Manufacturer SRN: CA-MF-000023304
UDI-DI: 00686597200858
Basic UDI-DI: B-00686597200858
Reference: 90-1026
EMDN: W0105030402
EMDN description: HIV MULTIPLE ANTIBODY
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 04.07.2026 18:04

Manufacturer products Authorised representative products Authorised representative actors View details