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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
Iprasense, 100µm, 4-chambers vertical
Attain Technologies B.V.
·
,
Netherlands
Class A
CE/IVDR
CSCQ Specimen 3
Biochemical Diagnostics Inc
·
,
United States
IVD General
CE/IVDD
GUDID
on market
KUBUS, 20µm, 4-chambers vertical
Attain Technologies B.V.
·
,
Netherlands
Class A
CE/IVDR
Manual Slide Staining Set
Bio-Optica Milano S.p.A.
·
,
Italy
Class A
CE/IVDR
ETHYL GLUCURONIDE 500ng/mL 2x20mL
Biochemical Diagnostics Inc
·
,
United States
IVD General
CE/IVDD
GUDID
on market
SSHMOBE with Butalbital 3X 100mL
Biochemical Diagnostics Inc
·
,
United States
IVD General
CE/IVDD
GUDID
on market
CellVision, 12 micron, 2 chambers horizontal
Attain Technologies B.V.
·
,
Netherlands
Class A
CE/IVDR
CellVision, 12 micron, 6 chambers vertical
Attain Technologies B.V.
·
,
Netherlands
Class A
CE/IVDR
AUNZS19 Cutoff +50%, 20mL
Biochemical Diagnostics Inc
·
,
United States
IVD General
CE/IVDD
GUDID
on market
Hamilton Thorne, 10µm, pH strip
Attain Technologies B.V.
·
,
Netherlands
Class A
CE/IVDR
MDMA OXY & BUP, Cutoff +50%, 5mL
Biochemical Diagnostics Inc
·
,
United States
IVD General
CE/IVDD
GUDID
on market
HCG URINE CONTROL Negative/Low Positive 2x4mL KITBOX
Biochemical Diagnostics Inc
·
,
United States
IVD General
CE/IVDD
GUDID
on market
STAT-SKREEN-H with MDMA, OXY & BUP, POSITIVE CONTROL 6x20mL
Biochemical Diagnostics Inc
·
,
United States
IVD General
CE/IVDD
GUDID
on market
SERIES X-H, CUTOFF +25% 6x20mL
Biochemical Diagnostics Inc
·
,
United States
IVD General
CE/IVDD
GUDID
on market
SERIES III CUTOFF -25% 6x20mL
Biochemical Diagnostics Inc
·
,
United States
IVD General
CE/IVDD
GUDID
on market
Combo-H, Cutoff +50%, 6x20mL
Biochemical Diagnostics Inc
·
,
United States
IVD General
CE/IVDD
GUDID
on market
Combo-H, 3X Cutoff, 20mL
Biochemical Diagnostics Inc
·
,
United States
IVD General
CE/IVDD
GUDID
on market
CONFIRM 3, CUTOFF, 50mL
Biochemical Diagnostics Inc
·
,
United States
IVD General
CE/IVDD
GUDID
on market
CellVision, 100 micron, 4 chambers horizontal
Attain Technologies B.V.
·
,
Netherlands
Class A
CE/IVDR
ORAL-SKREEN, Cutoff +50%, 20mL
Biochemical Diagnostics Inc
·
,
United States
IVD General
CE/IVDD
GUDID
on market
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