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35 device results listed.

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LABScreen™ PRA Class I

LABScreen

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: One Lambda, Inc.
Manufacturer SRN: US-MF-000024901
UDI-DI: 00812117011561
Basic UDI-DI: 081211701LSLJ
Reference: LS1PRA
EMDN: W01030402
EMDN description: HLA ANTIBODY SCREENING
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 05.08.2026 15:38

Manufacturer products Authorised representative products Authorised representative actors View details

LABType™ SSO Typing Test

RSSO1A

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: One Lambda, Inc.
Manufacturer SRN: US-MF-000024901
UDI-DI: 00812117011042
Basic UDI-DI: 081211701SSOAZ
Reference: RSSO1A
EMDN: W01030403
EMDN description: HLA ANTIGEN TYPING
First on market country: Austria
Authorised representative: MDSS GmbH
Last updated: 05.08.2026 00:09

Manufacturer products Authorised representative products Authorised representative actors View details

C1qScreen Negative Control Serum

C1qScreen™ C1q

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagentSingle use

Manufacturer: One Lambda, Inc.
Manufacturer SRN: US-MF-000024901
UDI-DI: 00812117016641
Basic UDI-DI: 081211701C1Q5J
Reference: C1QS-NC
EMDN: W01030402
EMDN description: HLA ANTIBODY SCREENING
First on market country: Austria
Authorised representative: MDSS GmbH
Last updated: 05.08.2026 00:09

Manufacturer products Authorised representative products Authorised representative actors View details

C1qScreen™

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagentSingle use

Manufacturer: One Lambda, Inc.
Manufacturer SRN: US-MF-000024901
UDI-DI: 00812117016658
Basic UDI-DI: 081211701C1Q5J
Reference: C1Q
EMDN: W01030402
EMDN description: HLA ANTIBODY SCREENING
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 05.08.2026 00:09

Manufacturer products Authorised representative products Authorised representative actors View details

C1qScreen Class I Positive Control

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagentSingle use

Manufacturer: One Lambda, Inc.
Manufacturer SRN: US-MF-000024901
UDI-DI: 00812117017853
Basic UDI-DI: 081211701C1Q5J
Reference: C1QS-PC1
EMDN: W01030402
EMDN description: HLA ANTIBODY SCREENING
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 05.08.2026 00:09

Manufacturer products Authorised representative products Authorised representative actors View details

C1qScreen Class II Postive Control

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagentSingle use

Manufacturer: One Lambda, Inc.
Manufacturer SRN: US-MF-000024901
UDI-DI: 00812117017860
Basic UDI-DI: 081211701C1Q5J
Reference: C1QS-PC2
EMDN: W01030402
EMDN description: HLA ANTIBODY SCREENING
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 05.08.2026 00:09

Manufacturer products Authorised representative products Authorised representative actors View details

LinkSēq HLA-ABCDRDQB1 Typing Kit

LinkSēq™ HLA Typing Kits

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: One Lambda, Inc.
Manufacturer SRN: US-MF-000024901
UDI-DI: 00814695025251
Basic UDI-DI: 081469502LNQHM
Reference: 1054C-ABS
EMDN: W01030403
EMDN description: HLA ANTIGEN TYPING
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 16.07.2026 04:18

Manufacturer products Authorised representative products Authorised representative actors View details

SureTyper™

STTPGRX

IVD Class CIVDR 2017/746On the marketDirect markingProfessional testing

Manufacturer: One Lambda, Inc.
Manufacturer SRN: US-MF-000024901
UDI-DI: 00814695024933
Basic UDI-DI: 081469502STPK8
Reference: STTPGRX
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Austria
Authorised representative: MDSS GmbH
Last updated: 16.07.2026 04:18

Manufacturer products Authorised representative products Authorised representative actors View details

TypeStream™ Visual Software version 3.2

TSVPRG

IVD Class CIVDR 2017/746On the marketDirect markingProfessional testing

Manufacturer: One Lambda, Inc.
Manufacturer SRN: US-MF-000024901
UDI-DI: 00814695024445
Basic UDI-DI: 081469502TSVKN
Reference: TSVPGR
EMDN: W02050292
EMDN description: MICRO-ARRAY INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Austria
Authorised representative: MDSS GmbH
Last updated: 16.07.2026 04:18

Manufacturer products Authorised representative products Authorised representative actors View details

SeCore™ A Locus Sequencing Kit

SeCore™ HLA Sequencing System

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: One Lambda, Inc.
Manufacturer SRN: US-MF-000024901
UDI-DI: 00814695021697
Basic UDI-DI: 081469502SECGZ
Reference: 5300025
EMDN: W01030403
EMDN description: HLA ANTIGEN TYPING
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 16.07.2026 04:18

Manufacturer products Authorised representative products Authorised representative actors View details

PE Conjugated Goat Anti-Human IgG

IVD Class CNot specifiedOn the marketSingle use

Manufacturer: One Lambda, Inc.
Manufacturer SRN: US-MF-000024901
UDI-DI: 00812117015231
Basic UDI-DI: 081211701LSLJ
Reference: LS-AB2
EMDN: W01030402
EMDN description: HLA ANTIBODY SCREENING
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 17.06.2026 07:10

Manufacturer products Authorised representative products Authorised representative actors View details

LABScreen™ Negative Control

IVD Class CNot specifiedOn the marketSingle use

Manufacturer: One Lambda, Inc.
Manufacturer SRN: US-MF-000024901
UDI-DI: 00812117015224
Basic UDI-DI: 081211701LSLJ
Reference: LS-NC
EMDN: W01030402
EMDN description: HLA ANTIBODY SCREENING
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 17.06.2026 07:10

Manufacturer products Authorised representative products Authorised representative actors View details

LABScreen™ Single Antigen HLA Class II ExPlex - Group 2

IVD Class CNot specifiedOn the marketSingle use

Manufacturer: One Lambda, Inc.
Manufacturer SRN: US-MF-000024901
UDI-DI: 00814695025961
Basic UDI-DI: 081211701LSLJ
Reference: LS2AEX02
EMDN: W01030402
EMDN description: HLA ANTIBODY SCREENING
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 17.06.2026 06:49

Manufacturer products Authorised representative products Authorised representative actors View details

SeCore™ A Locus Sequencing Kit

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: One Lambda, Inc.
Manufacturer SRN: US-MF-000024901
UDI-DI: 00814695022823
Basic UDI-DI: 081469502SECGZ
Reference: 22000D
EMDN: W01030403
EMDN description: HLA ANTIGEN TYPING
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 16.06.2026 23:37

Manufacturer products Authorised representative products Authorised representative actors View details

SeCore™ B Locus Sequencing Kit, Single Amplification

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: One Lambda, Inc.
Manufacturer SRN: US-MF-000024901
UDI-DI: 00814695022830
Basic UDI-DI: 081469502SECGZ
Reference: 22110D
EMDN: W01030403
EMDN description: HLA ANTIGEN TYPING
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 16.06.2026 23:37

Manufacturer products Authorised representative products Authorised representative actors View details

SeCore™ B Locus Sequencing Kit, Single Amplification

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: One Lambda, Inc.
Manufacturer SRN: US-MF-000024901
UDI-DI: 00814695022854
Basic UDI-DI: 081469502SECGZ
Reference: 5311025D
EMDN: W01030403
EMDN description: HLA ANTIGEN TYPING
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 16.06.2026 23:37

Manufacturer products Authorised representative products Authorised representative actors View details

LinkSēq HLA-ABCDRDQB1 Typing Kit

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: One Lambda, Inc.
Manufacturer SRN: US-MF-000024901
UDI-DI: 00814695025268
Basic UDI-DI: 081469502LNQHM
Reference: 1054C-RLC
EMDN: W01030403
EMDN description: HLA ANTIGEN TYPING
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 16.06.2026 23:37

Manufacturer products Authorised representative products Authorised representative actors View details

LinkSēq HLA-ABCDRDQA1DQB1 384 Typing Kit

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: One Lambda, Inc.
Manufacturer SRN: US-MF-000024901
UDI-DI: 00814695025299
Basic UDI-DI: 081469502LNQHM
Reference: 1550C
EMDN: W01030403
EMDN description: HLA ANTIGEN TYPING
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 16.06.2026 23:37

Manufacturer products Authorised representative products Authorised representative actors View details

LinkSēq HLA-ABCDRDQB1 384 Typing Kit

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: One Lambda, Inc.
Manufacturer SRN: US-MF-000024901
UDI-DI: 00814695025312
Basic UDI-DI: 081469502LNQHM
Reference: 1551C
EMDN: W01030403
EMDN description: HLA ANTIGEN TYPING
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 16.06.2026 23:37

Manufacturer products Authorised representative products Authorised representative actors View details

LinkSēq HLA-ABCDRDQB1 384 Typing Kit

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: One Lambda, Inc.
Manufacturer SRN: US-MF-000024901
UDI-DI: 00814695025336
Basic UDI-DI: 081469502LNQHM
Reference: 1554C
EMDN: W01030403
EMDN description: HLA ANTIGEN TYPING
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 16.06.2026 23:37

Manufacturer products Authorised representative products Authorised representative actors View details