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Calibrators and standards (clinical chemistry)
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Calibrators and standards (clinical chemistry) - other
Calibrators and standards (clinical chemistry) - other
W0101050399
189 devices
Standard solution
DIAMOND DIAGNOSTICS Inc
·
,
United States
Class A
CE/IVDR
Clinical Chemistry Calibrator
Dirui Industrial Co., Ltd
·
,
China
IVD General
CE/IVDD
AllDx
Hangzhou Aokai Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Z-Hb Confirm HbA1c Calibrator kit
ZOVEC diagnostics GmbH
·
,
Germany
IVD General
CE/IVDD
α-L-Fucosidase (AFU) Calibrator
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Mission Control
DIAMOND DIAGNOSTICS Inc
·
,
United States
Class A
CE/IVDR
Standard solution
DIAMOND DIAGNOSTICS Inc
·
,
United States
Class A
CE/IVDR
GUDID
on market
Calibrator solution
DIAMOND DIAGNOSTICS Inc
·
,
United States
Class A
CE/IVDR
Aptiva® Optical Calibrator Kit
Inova Diagnostics, Inc.
·
,
United States
Class A
CE/IVDR
GUDID
on market
Lambda Free Light Chains Calibrator
Medicon Hellas SA
·
,
Greece
Class B
CE/IVDR
Cal-Pack 644
Przedsiębiorstwo Produkcji i Handlu MEDRIV Sp. z o.o.
·
,
Poland
IVD General
CE/IVDD
Reference 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
Calibrator solution
DIAMOND DIAGNOSTICS Inc
·
,
United States
Class A
CE/IVDR
GUDID
on market
Mission Control
DIAMOND DIAGNOSTICS Inc
·
,
United States
Class A
FDA 510(k)
K033063
Active
Cleared 12 Dec 2003
CE/IVDR
+1
authorizations
Fluid pack
DIAMOND DIAGNOSTICS Inc
·
,
United States
Class A
CE/IVDR
GUDID
on market
HbA1c Hemoglobin Standard
C.P.M. Compagnia Per La Medicina S.R.L.
·
,
Italy
IVD General
CE/IVDD
Fluid pack
DIAMOND DIAGNOSTICS Inc
·
,
United States
Class A
CE/IVDR
GUDID
on market
Tuning solution for the derivatized internal standard
Immundiagnostik AG
·
,
Germany
Class A
CE/IVDR
Clinical Chemistry Calibrator
Dirui Industrial Co., Ltd
·
,
China
IVD General
CE/IVDD
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