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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
Negative Urine Control, 500mL
Biochemical Diagnostics Inc
·
,
United States
IVD General
CE/IVDD
GUDID
on market
CellVision, 30 micron, 2 chambers vertical
Attain Technologies B.V.
·
,
Netherlands
Class A
CE/IVDR
GC/MS-H CUTOFF -25%, 10x50mL
Biochemical Diagnostics Inc
·
,
United States
IVD General
CE/IVDD
GUDID
on market
DOA SCREEN Cutoff -25% 6x20 mL pack
Biochemical Diagnostics Inc
·
,
United States
IVD General
CE/IVDD
GUDID
on market
CellVision, 10 micron, 2 chambers vertical
Attain Technologies B.V.
·
,
Netherlands
Class A
CE/IVDR
BluePrint FFPE microarray
Agendia N.V
·
,
Netherlands
Class C
CE/IVDR
SSMOB, 3X, 50mL
Biochemical Diagnostics Inc
·
,
United States
IVD General
CE/IVDD
GUDID
on market
HT - Microptic, 20µm, 2-chambers vertical
Attain Technologies B.V.
·
,
Netherlands
Class A
CE/IVDR
AU/NZ SKREEN, Cutoff -50%, 5mL
Biochemical Diagnostics Inc
·
,
United States
IVD General
CE/IVDD
GUDID
on market
Acella, 100µm, 1-chamber SED
Attain Technologies B.V.
·
,
Netherlands
Class A
CE/IVDR
SERIES IX, Cutoff +25%, 20mL
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
CellVision, 200 micron, Fuchs Rosenthal
Attain Technologies B.V.
·
,
Netherlands
Class A
CE/IVDR
PREGNANCY-SKREEN hCG Liquid Control Serum -/+ Low Positive 2x4mL
Open recall
Biochemical Diagnostics Inc
·
,
United States
IVD General
FDA 510(k)
K050328
Active
Cleared 29 Mar 2005
CE/IVDD
JWH-073 4-Butanoic Acid, 100ng/mL, 5mL
Biochemical Diagnostics Inc
·
,
United States
IVD General
CE/IVDD
GUDID
on market
Iprasense, 20µm, 4-chambers vertical
Attain Technologies B.V.
·
,
Netherlands
Class A
CE/IVDR
Jwh-018 5-Pentanoic Acid Urine Control Kitbox
Biochemical Diagnostics Inc
·
,
United States
IVD General
CE/IVDD
GUDID
on market
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