BioCheck IgE EIA Test Kit - BioCheck IgE EIA Test Kit is intended for the - BIOCHECK, INC.

Duns Number:171857493

Device Description: BioCheck IgE EIA Test Kit is intended for the quantitative determination of immunoglobulin BioCheck IgE EIA Test Kit is intended for the quantitative determination of immunoglobulin E (IgE) in human serum.

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More Product Details

Catalog Number

BC-1035

Brand Name

BioCheck IgE EIA Test Kit

Version/Model Number

BC-1035

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

K992528

Product Code Details

Product Code

DGC

Product Code Name

Ige, Antigen, Antiserum, Control

Device Record Status

Public Device Record Key

5369ee29-2768-45ac-aeb1-eb6107298e4e

Public Version Date

October 16, 2019

Public Version Number

1

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