BioCheck Beta-2 Microglobulin EIA Test Kit - The BioCheck Beta-2 Microglobulin EIA Test Kit is - BIOCHECK, INC.

Duns Number:171857493

Device Description: The BioCheck Beta-2 Microglobulin EIA Test Kit is intended for the quantitative determinat The BioCheck Beta-2 Microglobulin EIA Test Kit is intended for the quantitative determination of beta-2 microglobulin concentration in human serum.

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More Product Details

Catalog Number

BC-1061

Brand Name

BioCheck Beta-2 Microglobulin EIA Test Kit

Version/Model Number

BC-1061

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K001022

Product Code Details

Product Code

JZG

Product Code Name

System, Test, Beta-2-Microglobulin Immunological

Device Record Status

Public Device Record Key

57fafaee-879e-4f61-896a-b92c66ac29d5

Public Version Date

October 10, 2022

Public Version Number

2

DI Record Publish Date

October 08, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIOCHECK, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 10