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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
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
Clinical Chemistry Calibrator
Dirui Industrial Co., Ltd
·
,
China
IVD General
CE/IVDD
β‐2 Microglobulin 4 levels Standard
C.P.M. Compagnia Per La Medicina S.R.L.
·
,
Italy
IVD General
CE/IVDD
Reference 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
Tuning solution for the internal standard
Immundiagnostik AG
·
,
Germany
Class A
CE/IVDR
Calibrator solution
DIAMOND DIAGNOSTICS Inc
·
,
United States
Class A
CE/IVDR
GUDID
on market
HDL/LDL Calibrator
Cypress Diagnostics
·
,
Belgium
IVD General
CE/IVDD
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