Skip to content
devi
CERTS
Devices
Categories
Manufacturers
Importers
Certifiers
Authorities
Reps.
Representatives
Categories
/
In vitro diagnostic medical devices
/
Reagents
/
Clinical chemistry
/
Controls/standards/calibrators clinical chemistry
/
Calibrators and standards (clinical chemistry)
Calibrators and standards (clinical chemistry)
W01010503
463 devices
Subcategories
4
W0101050301
Calibrators multicomponent (cc)
136
devices
W0101050302
Calibrators single component (cc)
109
devices
W0101050303
Aqueous standards (cc)
29
devices
W0101050399
Calibrators and standards (clinical chemistry) - other
189
devices
Devices
Standard solution
DIAMOND DIAGNOSTICS Inc
·
,
United States
Class A
CE/IVDR
Ferritin Standard
C.P.M. Compagnia Per La Medicina S.R.L.
·
,
Italy
IVD General
CE/IVDD
Standard solution
DIAMOND DIAGNOSTICS Inc
·
,
United States
Class A
CE/IVDR
GUDID
on market
Clinical Chemistry Calibrator
Dirui Industrial Co., Ltd
·
,
China
IVD General
CE/IVDD
Kondycjoner Elektrody Na
Przedsiębiorstwo Produkcji i Handlu MEDRIV Sp. z o.o.
·
,
Poland
IVD General
CE/IVDD
High sensitivity C-reactive protein(hs-CRP) Calibrator
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Mission trinity
DIAMOND DIAGNOSTICS Inc
·
,
United States
Class A
CE/IVDR
GUDID
on market
AllDx
Hangzhou Aokai Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Cal-Pack 348/348EX
Przedsiębiorstwo Produkcji i Handlu MEDRIV Sp. z o.o.
·
,
Poland
IVD General
CE/IVDD
Rheumatoid Factor (RF) Calibrator
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Bicarbonate Calibrator
Beckman Coulter Ireland Inc.
·
,
Ireland
Class B
FDA 510(k)
K141374
Active
Cleared 30 Jun 2014
CE/IVDR
+1
authorizations
MassTrak™ Steroid Serum Cal Set 3
Waters Corporation
·
,
United States
Class B
CE/IVDR
GUDID
on market
Calibrator solution
DIAMOND DIAGNOSTICS Inc
·
,
United States
Class A
CE/IVDR
GUDID
on market
Electrolyte solution
DIAMOND DIAGNOSTICS Inc
·
,
United States
Class A
CE/IVDR
GUDID
on market
Glycosylated Hemoglobin A1c (HbA1c) Calibrator
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Mission trinity
DIAMOND DIAGNOSTICS Inc
·
,
United States
Class A
CE/IVDR
GUDID
on market
Reference solution
DIAMOND DIAGNOSTICS Inc
·
,
United States
Class A
CE/IVDR
Standard solution
DIAMOND DIAGNOSTICS Inc
·
,
United States
Class A
CE/IVDR
GUDID
on market
Endotoxin LPS Control
Dynamiker Biotechnology (Tianjin) Co., Ltd.
·
,
China
IVD General
CE/IVDD
Buffer pack
DIAMOND DIAGNOSTICS Inc
·
,
United States
Class A
CE/IVDR
Previous
Next