HEp-2000® Fluorescent ANA-Ro Test System - Custom - HEp-2000® FA ANA-Ro BP - 1300 Tests - IMMUNO CONCEPTS INC

Duns Number:038271904

Device Description: Custom - HEp-2000® FA ANA-Ro BP - 1300 Tests

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More Product Details

Catalog Number

8224-Ro

Brand Name

HEp-2000® Fluorescent ANA-Ro Test System

Version/Model Number

8224-Ro

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

Product Code Details

Product Code

-

Product Code Name

-

Device Record Status

Public Device Record Key

1558a36a-d721-463d-83b6-80187c340909

Public Version Date

November 14, 2019

Public Version Number

3

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"IMMUNO CONCEPTS INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 2