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In vitro diagnostic medical devices
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IVD generic use consumables
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Devices for samples analyses (no laboratory generic products)
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Devices for samples analyses - various
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Devices for samples analyses - other
Devices for samples analyses - other
W05039099
307 devices
AU/NZ SKREEN, Cutoff +50%, 20mL
Biochemical Diagnostics Inc
·
,
United States
IVD General
CE/IVDD
GUDID
on market
HT - Microptic, 20µm, 4-chambers vertical
Attain Technologies B.V.
·
,
Netherlands
Class A
CE/IVDR
Combo-A, 3X Cutoff, 20mL
Biochemical Diagnostics Inc
·
,
United States
IVD General
CE/IVDD
GUDID
on market
CellVision, 10 micron, 6 chambers vertical
Attain Technologies B.V.
·
,
Netherlands
Class A
CE/IVDR
Fast Read 102
Biosigma S.P.A.
·
,
Italy
Class A
CE/IVDR
CellVision, 10 micron, 4 chambers horizontal
Attain Technologies B.V.
·
,
Netherlands
Class A
CE/IVDR
Custom Oral Fluid, AU/NZ Cutoff +50%, 5mL
Biochemical Diagnostics Inc
·
,
United States
IVD General
CE/IVDD
GUDID
on market
Buprenorphine 5ng/mL, 5mL
Biochemical Diagnostics Inc
·
,
United States
IVD General
CE/IVDD
GUDID
on market
CellVision, 20 micron, 6 chambers vertical
Attain Technologies B.V.
·
,
Netherlands
Class A
CE/IVDR
M-T System
Biosigma S.P.A.
·
,
Italy
Class A
CE/IVDR
Negative Urine Control, 1L
Biochemical Diagnostics Inc
·
,
United States
IVD General
CE/IVDD
GUDID
on market
Negative Urine Control 6x20mL
Biochemical Diagnostics Inc
·
,
United States
IVD General
CE/IVDD
GUDID
on market
SERIES IX, CUTOFF -25% 6x20mL
Biochemical Diagnostics Inc
·
,
United States
IVD General
CE/IVDD
GUDID
on market
Life Optic, 20µm, 4-chambers vertical
Attain Technologies B.V.
·
,
Netherlands
Class A
CE/IVDR
Custom Oral Fluid, Negative, 5mL
Biochemical Diagnostics Inc
·
,
United States
IVD General
CE/IVDD
GUDID
on market
CellVision, 12 micron, 2 chambers vertical
Attain Technologies B.V.
·
,
Netherlands
Class A
CE/IVDR
STAT-SKREEN, Cutoff +50%, 20mL
Biochemical Diagnostics Inc
·
,
United States
IVD General
CE/IVDD
GUDID
on market
STAT-SKREEN 17H, 2x10mL
Biochemical Diagnostics Inc
·
,
United States
IVD General
CE/IVDD
GUDID
on market
HT - Microptic, 10µm, 2-chambers vertical
Attain Technologies B.V.
·
,
Netherlands
Class A
CE/IVDR
LensHooke® X QC Reticle (For Semen)
Bonraybio Co., Ltd.
·
,
Taiwan
Class A
CE/IVDR
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