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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
Neonatal Phenylalanine Controls
Labsystems Diagnostics Oy
·
,
Finland
IVD Annex II List B
CE/IVDD
Calibrator solution
DIAMOND DIAGNOSTICS Inc
·
,
United States
Class A
CE/IVDR
GUDID
on market
UF-Calibrator
Sysmex Corporation
·
,
Japan
IVD General
CE/IVDD
System Calibrator
Beckman Coulter Ireland Inc.
·
,
Ireland
Class C
FDA 510(k)
K141388
Active
Cleared 11 Jul 2014
CE/IVDR
+1
authorizations
Rheumatoid Factor (RF) Calibrator
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Standard solution
DIAMOND DIAGNOSTICS Inc
·
,
United States
Class A
CE/IVDR
GUDID
on market
Selectivity check
DIAMOND DIAGNOSTICS Inc
·
,
United States
Class A
CE/IVDR
Clinical Chemistry Calibrator
Dirui Industrial Co., Ltd
·
,
China
IVD General
CE/IVDD
Standard solution
DIAMOND DIAGNOSTICS Inc
·
,
United States
Class A
CE/IVDR
GUDID
on market
Calibration solution
DIAMOND DIAGNOSTICS Inc
·
,
United States
Class A
CE/IVDR
Rheumatoid Factor Standard
C.P.M. Compagnia Per La Medicina S.R.L.
·
,
Italy
IVD General
CE/IVDD
β2-Microglobulin (β2-MG) Calibrator
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Wash-Pack 348/348EX
Przedsiębiorstwo Produkcji i Handlu MEDRIV Sp. z o.o.
·
,
Poland
IVD General
CE/IVDD
Standard solution
DIAMOND DIAGNOSTICS Inc
·
,
United States
Class A
CE/IVDR
GUDID
on market
Fluid pack
DIAMOND DIAGNOSTICS Inc
·
,
United States
Class A
CE/IVDR
GUDID
on market
Urine Calibrator
Beckman Coulter Ireland Inc.
·
,
Ireland
Class C
CE/IVDR
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
GUDID
on market
Mission trinity
DIAMOND DIAGNOSTICS Inc
·
,
United States
Class A
CE/IVDR
GUDID
on market
Calibrator solution
DIAMOND DIAGNOSTICS Inc
·
,
United States
Class A
CE/IVDR
GUDID
on market
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