Manufacturer

Biolytical

CanadaLegal entities : bioLytical Laboratories Inc.

Markets : Netherlands · United States

Approvals : United States (FDA) – · class II, III

EU representative : Emergo Europe B.V. (Netherlands)

3 categories, 42 models including 42 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
HIV multiple antibody	W0105030402	48 INSTI HIV-1/HIV-2 ANTIBODY TEST 90-1026-00198/79 48 INSTI HIV-1/HIV-2 ANTIBODY TEST 90-1026-00298/79 48 INSTI HIV-1/HIV-2 ANTIBODY TEST 90-1026-00398/79 INSTI HIV ANTIBODY SELF-TEST 90-1058-001 and 90-1058-00298/79 INSTI HIV ANTIBODY SELF-TEST 90-1123-00198/79 31 others INSTI HIV ANTIBODY SELF-TEST 90-1126-001 and 90-1126-00298/79 INSTI HIV Self Test (no pipette variant, packaged in a box) 90-105098/79 INSTI HIV Self Test (no pipette variant, packaged in a box) 90-105698/79 INSTI HIV Self Test (no pipette variant, packaged in a box) 90-105798/79 INSTI HIV Self Test (no pipette variant, packaged in a box) 90-105898/79 INSTI HIV Self Test (no pipette variant, packaged in a box) 90-105998/79 INSTI HIV Self Test (no pipette variant, packaged in a box) 90-1059-001 and 90-1059-00298/79 INSTI HIV Self Test (no pipette variant, packaged in a box) 90-106098/79 INSTI HIV Self Test (no pipette variant, packaged in a box) 90-1060-001, 90-1060-002, 90-1060-003, and 90-1060-00498/79 INSTI HIV Self Test (no pipette variant, packaged in a box) 90-106398/79 INSTI HIV Self Test (no pipette variant, packaged in a box) 90-107698/79 INSTI HIV Self Test (no pipette variant, packaged in a box) 90-1076-003 and 90-1076-00498/79 INSTI HIV Self Test (no pipette variant, packaged in a box)) 90-1076-005 and 90-1076-00698/79 INSTI HIV Self Test (no pipette variant, packaged in a pouch) 90-1041-001 and 90-1041-00298/79 INSTI HIV Self Test (no pipette variant, packaged in a pouch) 90-1041-003 and 90-1041-01098/79 INSTI HIV Self Test (no pipette variant, packaged in a pouch) 90-1041-00798/79 INSTI HIV Self Test (no pipette variant, packaged in a pouch) 90-1041-014 and 90-1041-01598/79 INSTI HIV Self Test (no pipette variant, packaged in pouch) 90-1041-012 and 90-1041-01398/79 INSTI HIV-1/HIV-2 ANTIBODY TEST 90-1015-001 and 90-1015-00298/79 INSTI HIV-1/HIV-2 ANTIBODY TEST 90-1015-003 and 90-1015-00498/79 INSTI HIV-1/HIV-2 ANTIBODY TEST 90-1015-005 and 90-1015-00698/79 INSTI HIV-1/HIV-2 ANTIBODY TEST 90-1015-00898/79 INSTI HIV-1/HIV-2 ANTIBODY TEST 90-1015-00998/79 INSTI HIV-1/HIV-2 ANTIBODY TEST 90-1015-01098/79 INSTI HIV-1/HIV-2 ANTIBODY TEST 90-1015-011 and 90-1015-01298/79 INSTI HIV-1/HIV-2 ANTIBODY TEST 90-1015-013 and 90-1015-01498/79 INSTI HIV-1/HIV-2 ANTIBODY TEST 90-1015-015 and 90-1015-01698/79 INSTI HIV-1/HIV-2 ANTIBODY TEST 90-1015-017 and 90-1015-01898/79 INSTI HIV-1/HIV-2 ANTIBODY TEST 90-102698/79 INSïl HIV Self Test (no pipette variant, packaged in a box) 90-1056-001 and 90-1056-00298/79 INSïl HIV Self Test (no pipette variant, packaged in a box) 90-1057-001 and 90-1057-00298/79	– 98/79	EUDAMED record Report an error
Controls infectious immunology - RT & POC	W0105094001	INSTI HCV Test Controls 90-106798/79 INSTI HIV-1/HIV-2 Test Controls 90-103698/79 INSTI T. pallidum Test Controls 90-103298/79	– 98/79	EUDAMED record Report an error
HCV antibody (total)	W0105020303	INSTI HCV ANTIBODY TEST 90-1062-001, 90-1062-002, 90-1062-00398/79 INSTI HCV ANTIBODY TEST 90-1062-005 and 90-1062-00698/79 INSTI HCV Antibody Test Single 90-1062-01298/79	– 98/79	EUDAMED record Report an error

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