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Active filter:Manufacturer SRN:CA-MF-000023304

52 device results listed.

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INSTI HIV-1/HIV-2 ANTIBODY TEST

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: 01.08.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details

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

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: 01.08.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details

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

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: 01.08.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details

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

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: 01.08.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details

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

90-1059-001 and 90-1059-002

IVD Annex II List AIVDDOn the marketKitSelf testingSingle use

Manufacturer: bioLytical Laboratories Inc.
Manufacturer SRN: CA-MF-000023304
UDI-DI: 00686597200636
Basic UDI-DI: B-00686597200636
Reference: 90-1059-001 and 90-1059-002
EMDN: W0105030402
EMDN description: HIV MULTIPLE ANTIBODY
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 01.08.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details

INSTI HIV-1/HIV-2 ANTIBODY TEST

90-1015-010

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

Manufacturer: bioLytical Laboratories Inc.
Manufacturer SRN: CA-MF-000023304
UDI-DI: 00686597200414
Basic UDI-DI: B-00686597200414
Reference: 90-1015-010
EMDN: W0105030402
EMDN description: HIV MULTIPLE ANTIBODY
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 01.08.2026 10:03

Manufacturer products Authorised representative products Authorised representative actors View details

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

90-1076

IVD Annex II List AIVDDOn the marketKitSelf testingSingle use

Manufacturer: bioLytical Laboratories Inc.
Manufacturer SRN: CA-MF-000023304
UDI-DI: 00686597010761
Basic UDI-DI: B-00686597010761
Reference: 90-1076
EMDN: W0105030402
EMDN description: HIV MULTIPLE ANTIBODY
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 01.08.2026 10:03

Manufacturer products Authorised representative products Authorised representative actors View details

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

90-1063

IVD Annex II List AIVDDOn the marketKitSelf testingSingle use

Manufacturer: bioLytical Laboratories Inc.
Manufacturer SRN: CA-MF-000023304
UDI-DI: 00686597010631
Basic UDI-DI: B-00686597010631
Reference: 90-1063
EMDN: W0105030402
EMDN description: HIV MULTIPLE ANTIBODY
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 01.08.2026 10:03

Manufacturer products Authorised representative products Authorised representative actors View details

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

90-1060

IVD Annex II List AIVDDOn the marketKitSelf testingSingle use

Manufacturer: bioLytical Laboratories Inc.
Manufacturer SRN: CA-MF-000023304
UDI-DI: 00686597010600
Basic UDI-DI: B-00686597010600
Reference: 90-1060
EMDN: W0105030402
EMDN description: HIV MULTIPLE ANTIBODY
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 01.08.2026 10:03

Manufacturer products Authorised representative products Authorised representative actors View details

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

90-1059

IVD Annex II List AIVDDOn the marketKitSelf testingSingle use

Manufacturer: bioLytical Laboratories Inc.
Manufacturer SRN: CA-MF-000023304
UDI-DI: 00686597010594
Basic UDI-DI: B-00686597010594
Reference: 90-1059
EMDN: W0105030402
EMDN description: HIV MULTIPLE ANTIBODY
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 01.08.2026 10:03

Manufacturer products Authorised representative products Authorised representative actors View details

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

90-1058

IVD Annex II List AIVDDOn the marketKitSelf testingSingle use

Manufacturer: bioLytical Laboratories Inc.
Manufacturer SRN: CA-MF-000023304
UDI-DI: 00686597010587
Basic UDI-DI: B-00686597010587
Reference: 90-1058
EMDN: W0105030402
EMDN description: HIV MULTIPLE ANTIBODY
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 01.08.2026 10:03

Manufacturer products Authorised representative products Authorised representative actors View details

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

90-1057

IVD Annex II List AIVDDOn the marketKitSelf testingSingle use

Manufacturer: bioLytical Laboratories Inc.
Manufacturer SRN: CA-MF-000023304
UDI-DI: 00686597010570
Basic UDI-DI: B-00686597010570
Reference: 90-1057
EMDN: W0105030402
EMDN description: HIV MULTIPLE ANTIBODY
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 01.08.2026 10:03

Manufacturer products Authorised representative products Authorised representative actors View details

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

IVD Annex II List ANot specifiedOn the marketSingle use

Manufacturer: bioLytical Laboratories Inc.
Manufacturer SRN: CA-MF-000023304
UDI-DI: 00686597010563
Basic UDI-DI: B-00686597010563
Reference: 90-1056
EMDN: W0105030402
EMDN description: HIV MULTIPLE ANTIBODY
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 01.08.2026 10:03

Manufacturer products Authorised representative products Authorised representative actors View details

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

IVD Annex II List ANot specifiedOn the marketSingle use

Manufacturer: bioLytical Laboratories Inc.
Manufacturer SRN: CA-MF-000023304
UDI-DI: 00686597010501
Basic UDI-DI: B-00686597010501
Reference: 90-1050
EMDN: W0105030402
EMDN description: HIV MULTIPLE ANTIBODY
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 01.08.2026 10:03

Manufacturer products Authorised representative products Authorised representative actors View details

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 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