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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
Fast Read 102
Biosigma S.P.A.
·
,
Italy
Class A
CE/IVDR
Megapor, 20µm, 5-chambers vertical
Attain Technologies B.V.
·
,
Netherlands
Class A
CE/IVDR
SERIES IV-H CUTOFF -25%, 6x20mL
Biochemical Diagnostics Inc
·
,
United States
IVD General
CE/IVDD
GUDID
on market
CellVision, 20 micron, 2 chambers vertical
Attain Technologies B.V.
·
,
Netherlands
Class A
CE/IVDR
Cotinine, 5ml in baggie 400ng/ml
Biochemical Diagnostics Inc
·
,
United States
IVD General
CE/IVDD
Fast Read 102
Biosigma S.P.A.
·
,
Italy
Class A
CE/IVDR
hCG 4mL Kit Neg/Pos dropper
Biochemical Diagnostics Inc
·
,
United States
IVD General
CE/IVDD
GUDID
on market
CONFIRM 3, Cutoff -25%, 50mL
Biochemical Diagnostics Inc
·
,
United States
IVD General
CE/IVDD
GUDID
on market
Manual Slide Staining Set
Bio-Optica Milano S.p.A.
·
,
Italy
Class A
CE/IVDR
AU/NZ SKREEN, Cutoff +50%, 5mL
Biochemical Diagnostics Inc
·
,
United States
IVD General
CE/IVDD
GUDID
on market
CellVision, 50 micron, 6 chambers vertical
Attain Technologies B.V.
·
,
Netherlands
Class A
CE/IVDR
Negative 2x5ml kitbox
Biochemical Diagnostics Inc
·
,
United States
IVD General
CE/IVDD
GUDID
on market
Combo-U, 3X Cutoff, 6x20mL
Biochemical Diagnostics Inc
·
,
United States
IVD General
CE/IVDD
GUDID
on market
Oral Fluid Control, Neg/3X POS, 2x20mL
Biochemical Diagnostics Inc
·
,
United States
IVD General
CE/IVDD
GUDID
on market
Acella, 100µm, 1-chamber
Attain Technologies B.V.
·
,
Netherlands
Class A
CE/IVDR
CONFIRM 4, CUTOFF +25%, 10x50mL
Biochemical Diagnostics Inc
·
,
United States
IVD General
CE/IVDD
GUDID
on market
NEG & SS(LM)MOB, 2x20ml Neg/Pos kitbox
Biochemical Diagnostics Inc
·
,
United States
IVD General
CE/IVDD
GUDID
on market
SERIES VI CUTOFF -25% 6x20mL
Biochemical Diagnostics Inc
·
,
United States
IVD General
CE/IVDD
GUDID
on market
Spermlide, 20µm, 4-chambers vertical
Attain Technologies B.V.
·
,
Netherlands
Class A
CE/IVDR
STAT-SKREEN with low COC/OPI/METH, cutoff -50%, 20 mL
Biochemical Diagnostics Inc
·
,
United States
IVD General
CE/IVDD
GUDID
on market
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