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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
BIRR, 20µm, 5-chambers vertical
Attain Technologies B.V.
·
,
Netherlands
Class A
CE/IVDR
Specialty Diagnostix Panel 1, 5mL
Biochemical Diagnostics Inc
·
,
United States
IVD General
CE/IVDD
GUDID
on market
ORAL-SKREEN NEGATIVE, 20mL
Biochemical Diagnostics Inc
·
,
United States
IVD General
CE/IVDD
GUDID
on market
OXY/MDMA/EDD -50%, 20mL
Biochemical Diagnostics Inc
·
,
United States
IVD General
CE/IVDD
GUDID
on market
Eurofins QC1, 25mL
Biochemical Diagnostics Inc
·
,
United States
IVD General
CE/IVDD
GUDID
on market
CONFIRM 4 CUTOFF -25%, 10x50mL
Biochemical Diagnostics Inc
·
,
United States
IVD General
CE/IVDD
GUDID
on market
CellVision, 30 micron, 6 chambers vertical
Attain Technologies B.V.
·
,
Netherlands
Class A
CE/IVDR
MDMA/6-MAM, -50%, 20mL
Biochemical Diagnostics Inc
·
,
United States
IVD General
CE/IVDD
GUDID
on market
SERIES XV-H CUTOFF -25% 6x20mL
Biochemical Diagnostics Inc
·
,
United States
IVD General
CE/IVDD
GUDID
on market
LensHooke® X QC Slide (For Semen)
Bonraybio Co., Ltd.
·
,
Taiwan
Class A
CE/IVDR
AU/NZ SKREEN, Cutoff -50%, 20mL
Biochemical Diagnostics Inc
·
,
United States
IVD General
CE/IVDD
GUDID
on market
ETHYL GLUCURONIDE 250ng/mL 2x20mL
Biochemical Diagnostics Inc
·
,
United States
IVD General
CE/IVDD
GUDID
on market
SERIES IV 3X Cutoff 6x20mL
Biochemical Diagnostics Inc
·
,
United States
IVD General
CE/IVDD
GUDID
on market
Magapor, 20µm, 4-chambers vertical
Attain Technologies B.V.
·
,
Netherlands
Class A
CE/IVDR
CellVision, 100 micron, 2 chambers horizontal
Attain Technologies B.V.
·
,
Netherlands
Class A
CE/IVDR
SERIES X-H, 3X CUTOFF, 6x20mL
Biochemical Diagnostics Inc
·
,
United States
IVD General
CE/IVDD
GUDID
on market
STAT-SKREEN-H with MDMA, OXY & BUP, POSITIVE CONTROL 10x5ML
Biochemical Diagnostics Inc
·
,
United States
IVD General
CE/IVDD
GUDID
on market
CellVision, 16 micron, 4 chambers vertical
Attain Technologies B.V.
·
,
Netherlands
Class A
CE/IVDR
LensHooke® Liquefaction Test Cup
Bonraybio Co., Ltd.
·
,
Taiwan
Class A
CE/IVDR
CellVision, 20 micron, Sperm Counting Grid (Makler)
Attain Technologies B.V.
·
,
Netherlands
Class A
CE/IVDR
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