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In vitro diagnostic medical devices
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IVD instruments
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Microbiology instruments (cultures)
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Microbiology susceptibility / identification
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Antibiotic susceptibility analysers
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Antibiotic susceptibility analysers - consumables
Antibiotic susceptibility analysers - consumables
W0203010185
187 devices
MicroScan Pos MIC E 37
Beckman Coulter, Inc.
·
,
United States
Class B
CE/IVDR
MicroScan HNID Inoculum Broth
Beckman Coulter, Inc.
·
,
United States
Class A
CE/IVDR
GUDID
on market
MicroScan MH BROTH with 3% LHB
Beckman Coulter, Inc.
·
,
United States
Class A
CE/IVDR
GUDID
on market
MicroScan RENOK Disposable D-Inoculator Sets 60 count
Beckman Coulter, Inc.
·
,
United States
Class A
CE/IVDR
GUDID
on market
MicroScan Neg MIC Panel Type 40
Beckman Coulter, Inc.
·
,
United States
Class B
CE/IVDD
CE/IVDR
MicroScan Rapid Anaerobe ID Panel
Beckman Coulter, Inc.
·
,
United States
Class B
CE/IVDR
GUDID
on market
MicroScan Neg Urine Combo Panel Type 52
Beckman Coulter, Inc.
·
,
United States
IVD General
CE/IVDD
MicroScan Neg MIC EN 52
Beckman Coulter, Inc.
·
,
United States
Class B
CE/IVDD
CE/IVDR
MicroScan Neg Combo Panel Type 63
Beckman Coulter, Inc.
·
,
United States
IVD General
CE/IVDR
CE/IVDD
MicroScan Negative MIC NF 50
Beckman Coulter, Inc.
·
,
United States
IVD General
CE/IVDD
MicroScan Neg Urine Combo Panel Type 69
Beckman Coulter, Inc.
·
,
United States
IVD General
CE/IVDD
MicroScan Neg MIC 61
Beckman Coulter, Inc.
·
,
United States
Class B
CE/IVDR
MicroScan Pos Combo Panel Type 32
Beckman Coulter, Inc.
·
,
United States
IVD General
CE/IVDR
CE/IVDD
Colibrì PRIMARY TUBE FOR VITEK 2
Copan Wasp S.r.l.
·
,
Italy
Class A
CE/IVDR
GUDID
on market
MicroScan Pos MIC Panel Type 33
Beckman Coulter, Inc.
·
,
United States
IVD General
CE/IVDR
CE/IVDD
MicroScan Neg Urine Combo 81
Beckman Coulter, Inc.
·
,
United States
IVD General
CE/IVDR
CE/IVDD
MicroScan PROMPT Inoculation System-D
Beckman Coulter, Inc.
·
,
United States
Class A
FDA 510(k)
K221493
Active
Cleared 5 Apr 2023
CE/IVDR
+1
authorizations
MicroScan HNID Panel Type
Beckman Coulter, Inc.
·
,
United States
IVD General
CE/IVDD
MicroScan Neg Combo Panel Type 53
Beckman Coulter, Inc.
·
,
United States
IVD General
CE/IVDD
MicroScan Yeast Turbidity Standard
Beckman Coulter, Inc.
·
,
United States
Class A
CE/IVDR
GUDID
on market
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