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Immunochemistry (immunology)
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Standards and calibrators immunochemistry
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Standards and calibrators - immunochemistry - other
Standards and calibrators - immunochemistry - other
W0102152299
146 devices
Devices
Access Ultrasensitive hGH Calibrators
Beckman Coulter, Inc.
·
,
US
Class B
FDA 510(k)
K003098
Active
Cleared 20 Nov 2000
CE/IVDR
Evo Specific Standard G
Abd SRL
·
,
IT
Class A
CE/IVDR
Access Unconjugated Estriol (Calibrators)
Beckman Coulter, Inc.
·
,
US
Class C
CE/IVDR
GUDID
on market
Specific Proteins Calibrator
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
CN
Class C
CE/IVDR
Access Inhibin A (Calibrator)
Beckman Coulter, Inc.
·
,
US
Class C
CE/IVDR
GUDID
on market
Access Cortisol (Calibrator S0)
Open recall
Beckman Coulter, Inc.
·
,
US
Class C
FDA 510(k)
K223038
Active
Cleared 8 Feb 2023
CE/IVDR
+1
authorizations
Immunochemistry Systems CAL 3 Calibrator 3
Beckman Coulter, Inc.
·
,
US
IVD General
CE/IVDD
Access Testosterone Calibrators
Open recall
Beckman Coulter, Inc.
·
,
US
Class B
FDA 510(k)
K223405
Active
Cleared 13 Jan 2023
CE/IVDR
+1
authorizations
D-Dimer Calibrator
Shenzhen Mindray Bio-Medical Electronics Co., LTD
·
,
CN
Class C
CE/IVDR
Access Progesterone De Calibrators
Beckman Coulter, Inc.
·
,
US
Class B
CE/IVDR
Calibration plate. Box of 10
RefLab Aps
·
,
DK
Class A
CE/IVDR
Access HBc Ab QC
Beckman Coulter, Inc.
·
,
US
IVD Annex II List A
CE/IVDD
CORMAY IgE CALIBRATORS
PZ CORMAY Spółka Akcyjna
·
,
PL
IVD General
CE/IVDD
Access 25(OH) Vitamin D Total Calibrators
Beckman Coulter, Inc.
·
,
US
Class B
CE/IVDR
GUDID
on market
Access Total T4 Calibrators
Beckman Coulter, Inc.
·
,
US
Class B
CE/IVDR
GUDID
on market
B·r·a·h·m·s Scc Kryptor Cal
B.R.A.H.M.S GmbH
·
,
DE
Class C
CE/IVDR
B·r·a·h·m·s Ca 19-9 Kryptor Cal
B.R.A.H.M.S GmbH
·
,
DE
Class C
CE/IVDR
Access Sensitive Estradiol Calibrator S0
Beckman Coulter, Inc.
·
,
US
Class B
CE/IVDR
Access HBc IgM Calibrators
Beckman Coulter, Inc.
·
,
US
IVD Annex II List A
CE/IVDD
Access Ostase Calibrators
Beckman Coulter, Inc.
·
,
US
Class B
CE/IVDR
GUDID
on market
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