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96 device results listed.

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MP Diagnostics HIV Ag/Ab Combo ELISA 4.0

23040-480

IVD Annex II List AIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testing

Manufacturer: MP Biomedicals Asia Pacific Pte Ltd
Manufacturer SRN: SG-MF-000024819
UDI-DI: 08887581002133
Basic UDI-DI: B-08887581002133
Reference: 23040-480
EMDN: W0105030404
EMDN description: HIV MULTIPLE AG/AB COMBI TEST
First on market country: Germany
Authorised representative: MP Biomedicals Germany GmbH
Last updated: 04.08.2026 14:48

Manufacturer products Authorised representative products Authorised representative actors View details

MP Diagnostics HIV Ag/Ab Combo ELISA 4.0

23040-096

IVD Annex II List AIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testing

Manufacturer: MP Biomedicals Asia Pacific Pte Ltd
Manufacturer SRN: SG-MF-000024819
UDI-DI: 08887581002126
Basic UDI-DI: B-08887581002126
Reference: 23040-096
EMDN: W0105030404
EMDN description: HIV MULTIPLE AG/AB COMBI TEST
First on market country: Germany
Authorised representative: MP Biomedicals Germany GmbH
Last updated: 04.08.2026 14:48

Manufacturer products Authorised representative products Authorised representative actors View details

MP Diagnostics MULTISURE HIV 1/2 Confirmatory Test

MP Diagnostics MULTISURE® HIV 1/2 Confirmatory Test

IVD Annex II List AIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: MP Biomedicals Asia Pacific Pte Ltd
Manufacturer SRN: SG-MF-000024819
UDI-DI: 08887581001839
Basic UDI-DI: B-08887581001839
Reference: 93030-020
EMDN: W0105030403
EMDN description: HIV MULTIPLE ANTIBODY - CONFIRMATORY
First on market country: Germany
Authorised representative: MP Biomedicals Germany GmbH
Last updated: 04.08.2026 14:48

Manufacturer products Authorised representative products Authorised representative actors View details

GB HIV Ag-Ab COMB

IVD Annex II List AIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: General Biologicals Corporation
Manufacturer SRN: TW-MF-000024694
UDI-DI: 04712803531327
Basic UDI-DI: B-04712803531327
Reference: 4EAIC13
EMDN: W0105030404
EMDN description: HIV MULTIPLE AG/AB COMBI TEST
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 02.08.2026 12:48

Manufacturer products Authorised representative products Authorised representative actors View details

GB HIV Ag-Ab COMB

IVD Annex II List AIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: General Biologicals Corporation
Manufacturer SRN: TW-MF-000024694
UDI-DI: 04712803531310
Basic UDI-DI: B-04712803531310
Reference: 4EAIC11
EMDN: W0105030404
EMDN description: HIV MULTIPLE AG/AB COMBI TEST
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 02.08.2026 12:48

Manufacturer products Authorised representative products Authorised representative actors View details

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

EIAgen Detect HIV Combo Kit

++M52108131C

IVD Annex II List AIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: ADALTIS SRL
Manufacturer SRN: IT-MF-000028990
UDI-DI: ++M52108131CB3
Basic UDI-DI: B-++M52108131CB3
Reference: 081311C / 081312C / 081315C
EMDN: W0105030404
EMDN description: HIV MULTIPLE AG/AB COMBI TEST
First on market country: Hungary
Authorised representative: -
Last updated: 01.08.2026 01:56

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