Catalog Number

-

Brand Name

Syphilis Control

Version/Model Number

2130170

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

-

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

OHQ

Product Code Name

Multi-Analyte Controls Unassayed

Public Device Record Key

1a7d6d2a-aead-45f3-a7da-17a650ebfa62

Public Version Date

July 15, 2020

Public Version Number

3

DI Record Publish Date

June 23, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-