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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
STAT-SKREEN, 3X Cutoff, 20mL
Biochemical Diagnostics Inc
·
,
United States
IVD General
CE/IVDD
GUDID
on market
STAT-SKREEN17H URINE POSITIVE CONTROL, 6x10mL
Biochemical Diagnostics Inc
·
,
United States
IVD General
CE/IVDD
GUDID
on market
HT - Microptic, 10µm, 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
AUNZS19 Cutoff -50%, 5mL
Biochemical Diagnostics Inc
·
,
United States
IVD General
CE/IVDD
GUDID
on market
Ongo Vettech, 20µm, Yellow
Attain Technologies B.V.
·
,
Netherlands
Class A
CE/IVDR
Stat-Skreen with low COC/OPI/METH, cutoff +50% 20mL
Biochemical Diagnostics Inc
·
,
United States
IVD General
CE/IVDD
GUDID
on market
STAT-SKREEN, Cutoff -50%, 20mL
Biochemical Diagnostics Inc
·
,
United States
IVD General
CE/IVDD
GUDID
on market
STAT-SKREEN17 POSITIVE CONTROL, 6x10mL
Biochemical Diagnostics Inc
·
,
United States
IVD General
CE/IVDD
GUDID
on market
CellVision, 16 micron, 2 chambers horizontal
Attain Technologies B.V.
·
,
Netherlands
Class A
CE/IVDR
GC/MS-H CUTOFF 10x50mL
Biochemical Diagnostics Inc
·
,
United States
IVD General
CE/IVDD
GUDID
on market
SERIES IV-H, Cutoff -25%, 20 mL
Biochemical Diagnostics Inc
·
,
United States
IVD General
CE/IVDD
GUDID
on market
Negative Urine Control 10x5mL
Biochemical Diagnostics Inc
·
,
United States
IVD General
CE/IVDD
GUDID
on market
MammaPrint BluePrint Breast Cancer Recurrence and Molecular Subtyping Kit
Agendia N.V
·
,
Netherlands
Class C
CE/IVDR
CellVision, 10 micron, Sperm Counting Grid (Makler)
Attain Technologies B.V.
·
,
Netherlands
Class A
CE/IVDR
STAT-SKREEN-H with MDMA, OXY & BUP 2x20mL KITBOX
Biochemical Diagnostics Inc
·
,
United States
IVD General
CE/IVDD
GUDID
on market
DOA SCREEN Cutoff +25% 6x20 mL pk
Biochemical Diagnostics Inc
·
,
United States
IVD General
CE/IVDD
GUDID
on market
Iprasense, 30µm, 4-chambers vertical
Attain Technologies B.V.
·
,
Netherlands
Class A
CE/IVDR
Exseed, 20µm, 2-chambers vertical
Attain Technologies B.V.
·
,
Netherlands
Class A
CE/IVDR
Combo-H, 3X Cutoff, 6x20mL
Biochemical Diagnostics Inc
·
,
United States
IVD General
CE/IVDD
GUDID
on market
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