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Results for “G6PDH”
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EUDAMED
3
FDA 510(k)
1
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GUDID
3
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1
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4
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1
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IVD Annex II List A
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IVD for self-testing
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7 devices found
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G6PDH
UDI-DI +G437155020+
Vitro Scient
·
,
Egypt
IVD General
CE/IVDD
Withdrawn
CE IVDD
, withdrawn
EUDAMED
IVD General
2 variants
G6PDH
15501
Withdrawn
G6PDH-RED CELL LYSING REAGENT (only for automation)
Ben S.R.L. Biochemical Enterprise
·
,
Italy
Class A
CE/IVDR
Active
CE IVDR
EUDAMED
A
Hemoglobin G6PDH Intermediate Control HC-108IN
Analytical Control Systems
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Hemoglobin G6PDH Normal Control HC-108
Analytical Control Systems
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Hemoglobin G6PDH Deficient Control HC-108DE
Analytical Control Systems
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
G6PDH, Glucose-6-Phoshate Dehydrogenase
Pointe Scientific, Inc.
·
,
United States
(FDA 510(k) applicant)
Class II
FDA 510(k)
K024006
Active
Cleared 31 Mar 2003
Active
510(k)
510(k)
II
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