Access HYPERsensitive hTSH - The Access HYPERsensitive hTSH assay is a - Beckman Coulter, Inc.

Duns Number:008254708

Device Description: The Access HYPERsensitive hTSH assay is a paramagnetic particle, chemiluminescent immunoas The Access HYPERsensitive hTSH assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of human thyroid-stimulating hormone (thyrotropin, hTSH) levels in human serum and plasma using the Access Immunoassay Systems.

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More Product Details

Catalog Number

33820

Brand Name

Access HYPERsensitive hTSH

Version/Model Number

33820

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

JLW

Product Code Name

Radioimmunoassay, Thyroid-Stimulating Hormone

Device Record Status

Public Device Record Key

2ab8fd8c-b704-4098-a5d9-e34e6c7f59e6

Public Version Date

April 09, 2018

Public Version Number

3

DI Record Publish Date

September 09, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BECKMAN COULTER, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 319
2 A medical device with a moderate to high risk that requires special controls. 503
3 A medical device with high risk that requires premarket approval 9
U Unclassified 1