Catalog Number

-

Brand Name

Detector RPR

Version/Model Number

RPR-100NC

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

GMQ

Product Code Name

ANTIGENS, NONTREPONEMAL, ALL

Public Device Record Key

4885151f-b9f3-4ebc-b07b-5c1bc6715001

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 03, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-