Beckman Coulter, Inc.

Address:250 S Kraemer Blvd,BREA,CA,92821,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Reagent, Coronavirus Serological (QKO) (6) Calibrator, Secondary (JIT) (1) Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (1) System, Test, Automated, Antimicrobial Susceptibility, Short Incubation (LON) (1) Test, Natriuretic Peptide (NBC) (1)

Premarket Exempt

No Yes

Clear

Access SARS-CoV-2 IgG - 15099590738648 Catalog Number : C58961

Device Description : The Access SARS-CoV-2 IgG assay is a paramagnetic particle, chemiluminescent imm The Access SARS-CoV-2 IgG assay is a paramagnetic particle, chemiluminescent immunoassay intended for the qualitative detection of IgG antibodies to SARS-CoV-2 in human serum, serum separator tubes and plasma (lithium heparin, dipotassium EDTA, tripotassium EDTA, and sodium citrate). The Access SARS-CoV-2 IgG assay is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, that meet requirements to perform moderate or high complexity tests.The Access SARS-CoV-2 IgG assay is only for use under the Food and Drug Administration's Emergency Use Authorization.

Device Class :

Duns Number: 008254708

Premarket Exempt : Yes

Product Code : QKO

Prescription Use : Yes

Device Count : 1

Access SARS-CoV-2 IgG Calibrator - 15099590738655 Catalog Number : C58963

Device Description : The Access SARS-CoV-2 IgG Calibrators are intended to calibrate the Access SARS- The Access SARS-CoV-2 IgG Calibrators are intended to calibrate the Access SARS-CoV-2 IgG assay for the in vitro qualitative detection of SARS-CoV-2 IgG antibodies in human serum, serum separator tubes and plasma (lithium heparin, dipotassium EDTA, tripotassium EDTA, and sodium citrate) for use on the Access Family of Immunoassay Systems only. The Access SARS-CoV-2 IgG Calibrators are only for use under the Food and Drug Administration's Emergency Use Authorization.

Device Class :

Duns Number: 008254708

Premarket Exempt : Yes

Product Code : QKO

Prescription Use : Yes

Device Count : 1

Access SARS-CoV-2 IgG QC - 15099590738662 Catalog Number : C58964

Device Description : The Access SARS-CoV-2 IgG QC is intended for monitoring system performance of th The Access SARS-CoV-2 IgG QC is intended for monitoring system performance of the Access SARS-CoV-2 IgG assay. The Access SARS-CoV-2 IgG QC is for use on the Access Family of Immunoassay Systems only.The Access SARS-CoV-2 IgG QC are only for use under the Food and Drug Administration's Emergency Use Authorization.

Device Class :

Duns Number: 008254708

Premarket Exempt : Yes

Product Code : QKO

Prescription Use : Yes

Device Count : 1

MicroScan - 15099590738884 Catalog Number : C62574

Device Description : DVD, LabPro V5.00 Data Delivery-01 (US, FMR)

Device Class :

Duns Number: 008254708

Premarket Exempt : No

Product Code : LON

Prescription Use : Yes

Device Count : 1

Access SARS-CoV-2 IgG II - 15099590742744 Catalog Number : C69057

Device Description : The Access SARS-CoV-2 IgG II assay is a paramagnetic particle, chemiluminescent The Access SARS-CoV-2 IgG II assay is a paramagnetic particle, chemiluminescent immunoassay intended for the semi-quantitative and qualitative detection of IgG antibodies to SARS-CoV-2 in human plasma (lithium heparin, dipotassium EDTA, tripotassium EDTA, and sodium citrate). The Access SARS-CoV-2 IgG II assay is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. The Access SARS-CoV-2 IgG II should not be used to diagnose or exclude acute SARS-CoV-2 infection. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, that meet requirements to perform moderate or high complexity tests.The Access SARS-CoV-2 IgG II assay is only for use under the Food and Drug Administration's Emergency Use Authorization.

Device Class :

Duns Number: 008254708

Premarket Exempt : Yes

Product Code : QKO

Prescription Use : Yes

Device Count : 1

Access SARS-CoV-2 IgG II Calibrator - 15099590742751 Catalog Number : C69058

Device Description : The Access SARS-CoV-2 IgG II Calibrators are intended to calibrate the Access SA The Access SARS-CoV-2 IgG II Calibrators are intended to calibrate the Access SARS-CoV-2 IgG II assay for the in vitro semi-quantitative and qualitative detection of SARS-CoV-2 IgG antibodies in human plasma (lithium heparin, dipotassium EDTA, tripotassium EDTA, and sodium citrate) for use on the Access Immunoassay Systems only.The Access SARS-CoV-2 IgG II calibrators are only for use under the Food and Drug Administration's Emergency Use Authorization.

Device Class :

Duns Number: 008254708

Premarket Exempt : Yes

Product Code : QKO

Prescription Use : Yes

Device Count : 1

Access SARS-CoV-2 IgG II QC - 15099590742768 Catalog Number : C69059

Device Description : The Access SARS-CoV-2 IgG II QC is intended for monitoring system performance of The Access SARS-CoV-2 IgG II QC is intended for monitoring system performance of the Access SARS-CoV-2 IgG II assay using the Access Immunoassay Systems only.The Access SARS-CoV-2 IgG II QC are only for use under the Food and Drug Administration's Emergency Use Authorization.

Device Class :

Duns Number: 008254708

Premarket Exempt : Yes

Product Code : QKO

Prescription Use : Yes

Device Count : 1

Access BNP - 15099590750947 Catalog Number : 98200

Device Description : The Access BNP test is intended for use with the Beckman Coulter Access Family o The Access BNP test is intended for use with the Beckman Coulter Access Family of Immunoassay Systems for the In Vitro quantitative measurement of B-type natriuretic peptide (BNP) in plasma specimens using EDTA as the anticoagulant. The test is intended to be used for the following indications:• as an aid in the diagnosis of congestive heart failure (also referred to as heart failure)• as an aid in the assessment of severity of congestive heart failure • for the risk stratification of patients with acute coronary syndromes• for the risk stratification of patients with heart failure

Device Class : 2

Duns Number: 008254708

Premarket Exempt : No

Product Code : NBC

Prescription Use : Yes

Device Count : 1

Access BNP QC - 15099590750954 Catalog Number : 98201

Device Description : The Access BNP QC Controls are intended for monitoring the performance of the Ac The Access BNP QC Controls are intended for monitoring the performance of the Access BNP test using the Beckman Coulter Access Family of Immunoassay Systems.

Device Class : 1

Duns Number: 008254708

Premarket Exempt : Yes

Product Code : JJX

Prescription Use : Yes

Device Count : 1

Access BNP Calibrators - 15099590750961 Catalog Number : 98202

Device Description : The Access BNP Calibrators are intended to calibrate the Access BNP test for the The Access BNP Calibrators are intended to calibrate the Access BNP test for the quantitative determination of BNP levels in human EDTA plasma using the Beckman Coulter Access Family of Immunoassay Systems.

Device Class : 2

Duns Number: 008254708

Premarket Exempt : Yes

Product Code : JIT

Prescription Use : Yes

Device Count : 1

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