Beckman Coulter, Inc.

Address:740 WEST 83RD ST.,HIALEAH,FL,33014,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

Manual Antimicrobial Susceptibility Test Systems (JWY) (3) Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems (LRG) (3) Susceptibility Test Cards, Antimicrobial (LTW) (3) Gram Negative Identification Panel (LQM) (3) Panels, Test, Susceptibility, Antimicrobial (LTT) (3) Total,Prostate Specific Antigen(Noncomplexed&Complexed) For Detection Of Prostate Cancer (MTF) (2) Kit, Test, Alpha-Fetoprotein For Neural Tube Defects (LOK) (2) Visual, Pregnancy Hcg, Prescription Use (JHI) (1) Radioassay, Vitamin B12 (CDD) (1) System, Test, Automated, Antimicrobial Susceptibility, Short Incubation (LON) (1)

Premarket Exempt

No Yes

Clear

MicroScan - 15099590765361 Catalog Number :

Device Description : Neg Urine Combo 101

Device Class : 1

Duns Number: 008254708

Premarket Exempt : No

Product Code : JWY, LRG, LTT, LTW, LQM

Prescription Use : Yes

Device Count : 20

MicroScan - 15099590765378 Catalog Number :

Device Description : Neg Urine Combo 102

Device Class : 1

Duns Number: 008254708

Premarket Exempt : No

Product Code : JWY, LRG, LTT, LTW, LQM

Prescription Use : Yes

Device Count : 20

MicroScan - 15099590765385 Catalog Number :

Device Description : Neg Urine Combo 103

Device Class : 1

Duns Number: 008254708

Premarket Exempt : No

Product Code : JWY, LRG, LTT, LTW, LQM

Prescription Use : Yes

Device Count : 20

MicroScan - 15099590772741 Catalog Number : C90679

Device Description : LabPro V5.0 Panel Update 10 (US), Electronic

Device Class : 2

Duns Number: 008254708

Premarket Exempt : No

Product Code : LON

Prescription Use : Yes

Device Count : 1

ICON 25 hCG - 15099590776886 Catalog Number : 43025

Device Description : Icon 25 HCG, Box of 25 Tests

Device Class : 2

Duns Number: 008254708

Premarket Exempt : No

Product Code : JHI

Prescription Use : Yes

Device Count : 1

Access Vitamin B12 - H628330001 Catalog Number : 33000

Device Class : 2

Duns Number: 008254708

Premarket Exempt : No

Product Code : CDD

Prescription Use : Yes

Device Count : 1

Access AFP - H628332111 Catalog Number : 33211

Device Description : The Access AFP assay is a paramagnetic particle, chemiluminescent immunoassay fo The Access AFP assay is a paramagnetic particle, chemiluminescent immunoassay for use with the Access Immunoassay Systems for the quantitative determination of alpha-fetoprotein (AFP) in:1. Human serum, as an aid in the management of patients with non-seminomatous testicular cancer.2. Maternal serum and amniotic fluid at 15 to 20 weeks gestation, to aid in the detection of fetal open neural tube defects (ONTD). Test results, when used in conjunction with ultrasonography, are safe and effective aids in the detection of fetal ONTD. The assay is intended for use in conjunction with other diagnostic tools such as ultrasound and amniography.

Device Class : 3

Duns Number: 008254708

Premarket Exempt : No

Product Code : LOK

Prescription Use : Yes

Device Count : 1

Access AFP Sample Diluent - H628332161 Catalog Number : 33216

Device Description : The Access AFP Sample Diluent is intended for use with the Access AFP assay to d The Access AFP Sample Diluent is intended for use with the Access AFP assay to dilute patient samples containing AFP concentrations greater than the S6 calibrator.

Device Class : 3

Duns Number: 008254708

Premarket Exempt : No

Product Code : LOK

Prescription Use : Yes

Device Count : 1

Access Hybritech PSA - H628372001 Catalog Number : 37200

Device Description : The Access Hybritech PSA assay is a paramagnetic particle, chemiluminescent immu The Access Hybritech PSA assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total prostate specific antigen (PSA) levels in human serum using the Access Immunoassay Systems. This device is indicated for the measurement of serum PSA in conjunction with digital rectal examination (DRE) as an aid in the detection of prostate cancer in men aged 50 years or older. Prostate biopsy is required for the diagnosis of cancer. This device is further indicated for the serial measurement of PSA to aid in the prognosis and management of patients with prostate cancer.

Device Class : 3

Duns Number: 008254708

Premarket Exempt : No

Product Code : MTF

Prescription Use : Yes

Device Count : 1

Access Hybritech PSA Calibrators - H628372051 Catalog Number : 37205

Device Description : The Access Hybritech PSA Calibrators are intended to calibrate the Access Hybrit The Access Hybritech PSA Calibrators are intended to calibrate the Access Hybritech PSA assay for the quantitative determination of total prostate specific antigen (PSA) levels in human serum using the Access Immunoassay Systems.

Device Class : 3

Duns Number: 008254708

Premarket Exempt : No

Product Code : MTF

Prescription Use : Yes

Device Count : 1

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