Catalog Number

NC-900500-15

Brand Name

ASI RPR Card Test for Syphilis

Version/Model Number

NC-900500-15

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 16, 2017

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K851504

Product Code

GMP

Product Code Name

Antisera, Control For Nontreponemal Tests

Public Device Record Key

935bee3d-d5ad-4327-b3d3-76640d447fd8

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

March 16, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-