Manufacturer

One Lambda

United StatesLegal entities : One Lambda, Inc.

First countries of placing on the market declared in EUDAMED : Austria, Germany

EU representative : MDSS GmbH (Germany)

5 categories, 16 models including 16 on the market, 1 country

Category	EMDN code	Registered models	Class	Contact
Hla antigen typing	W01030403	AllType NGS Library Prep Kit3 refs AllType™ FASTplex™ NGS 11 Kit (Box 2 of 2) ALL-FAST11LF2 refs AllType™ FASTplex™ NGS 11 Loci Kit – 48 (Box 1 of 2) ALL-FAST11L HybriType™ HLA Plus 18 Loci Flex Kit – 4 Enrichments HYB18LF3 refs LABType™ CWD Class I A Locus Typing Test - 20 tests3 refs 3 others LABType™ SSO Class I A Locus Typing Test3 refs LinkSēq HLA-ABC 384 Typing Kit3 refs SeCore GSSP3 refs	C IVDR	EUDAMED record Report an error
Hla antibody screening	W01030402	C1qScreen Class I Positive Control C1qScreen™ C1q3 refs FlowPRA™ Class I Positive Control3 refs LABScreen™ MICA Single Antigen - Group 13 refs LABScreen™ Multi	C IVDR	EUDAMED record Report an error
Nucleic acid testing instruments except micro-arrays - IVD medical device software	W02050192	SureTyper™ STTPGRX uTYPE™ HLA Sequence Analysis Software 539992	C IVDR	EUDAMED record Report an error
Micro-array instruments - IVD medical device software	W02050292	TypeStream™ Visual Software version 3.2 TSVPRG	C IVDR	EUDAMED record Report an error
Various hematology / histology / cytology instruments - IVD medical device software	W02029092	HLA Fusion™ Software FUSPGR	C IVDR	EUDAMED record Report an error

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

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