Marsh Elder, Rough Iva ciliata - A substance or reactant intended to be used - HYCOR BIOMEDICAL LLC

Duns Number:010558476

Device Description: A substance or reactant intended to be used together with a parent IVD to perform a specif A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of an allergen specific immunoglobulin E (IgE) antibody in a clinical specimen.

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More Product Details

Catalog Number

74436

Brand Name

Marsh Elder, Rough Iva ciliata

Version/Model Number

W016

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

K841651

Product Code Details

Product Code

DGC

Product Code Name

Ige, Antigen, Antiserum, Control

Device Record Status

Public Device Record Key

8d9dfc3e-844b-422f-9514-3ea919e16b98

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

September 26, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HYCOR BIOMEDICAL LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 158
2 A medical device with a moderate to high risk that requires special controls. 148