Manufacturer

Ablsa

LuxembourgLegal entities : ADVANCED BIOLOGICAL LABORATORIES (ABL) S.A.

Markets : Luxembourg

8 categories, 33 models including 33 on the market, 1 country

On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
Nucleic acid testing instruments except micro-arrays - IVD medical device software	W02050192	BacterioChek® - TB Software98/79 DeepChek® - CMV Software98/79 DeepChek® - HBV Software98/79 DeepChek® - HCV Software98/79 DeepChek® - HIV Software98/79 3 others DeepChek® - HPV Software98/79 DeepChek® - HSV Software98/79 ViroScore® - HIV Software98/79	– 98/79	EUDAMED record Report an error
Coronavirus - NA reagents	W0105041106	UltraGene Assay SARS-CoV-298/79 UltraGene Assay SARS-CoV-2 PrimeChek V3 (1000 tests, liquid)98/79 UltraGene Assay SARS-CoV-2 PrimeChek V3 (50 tests, liquid)98/79 UltraGene Assay SARS-CoV-2 PrimeChek V3 (96 tests, lyophilized)98/79 UltraGene Assay SARS-CoV-2 VOC Screening & Determination V1.X98/79 2 others UltraGene Assay SARS-CoV-2 Universalis V2.X (1000 tests)98/79 UltraGene Assay SARS-CoV-2 Universalis V2.X (50 tests)98/79	– 98/79	EUDAMED record Report an error
HIV 1 genotyping - NA reagents	W0105030108	DeepChek® Assay INTEGRASE Genotyping and Drug Resistance V1.X98/79 DeepChek® Assay INTEGRASE Sequencing V1.X98/79 DeepChek® Assay PROTEASE / REVERSE TRANSCRIPTASE Genotyping and Drug Resistance V1.X98/79 DeepChek® Assay PROTEASE / REVERSE TRANSCRIPTASE Sequencing V1.X98/79 DeepChek® Assay Whole Genome HIV-1 Genotyping V1.X98/79	– 98/79	EUDAMED record Report an error
Influenza & para influenza / respiratory syncytial virus (rsv) / sars-cov - multiplex NA reagents	W0105070304	UltraGene Assay Combo 4 Screening V2.X (1000 tests)98/79 UltraGene Assay Combo 4 Screening V2.X (50 tests)98/79 UltraGene Assay FLU/HRSV (32 tests)98/79 UltraGene Assay FLU/HRSV (64 tests)98/79	– 98/79	EUDAMED record Report an error
Other virus combinations - multiplex NA reagents	W0105070302	UltraGene Assay Vesicular rash (32 tests)98/79 UltraGene Assay Vesicular rash (64 tests)98/79 UltraGene Assay Viral meningitis (32 tests)98/79 UltraGene Assay Viral meningitis (64 tests)98/79	– 98/79	EUDAMED record Report an error
Multiple parasites panels	W01050704	UltraGene Assay Stool parasites (32 tests)98/79 UltraGene Assay Stool parasites (64 tests)98/79	– 98/79	EUDAMED record Report an error
Respiratory tract infections - multiplex NA reagents	W0105070503	UltraGene Assay Respiratory pathogens 21 (32 tests)98/79 UltraGene Assay Respiratory pathogens 21 (64 tests)98/79	– 98/79	EUDAMED record Report an error
Mycobacteria reagents - other	W0105010799	DeepChek® Assay 13-Plex KB Drug Susceptibility Testing V1.X98/79	– 98/79	EUDAMED record Report an error

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