Catalog Number

CH-4112

Brand Name

Chlamydia Antigen Substrate, 12 wells, For IFA Test System

Version/Model Number

CH-4112

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K894625

Product Code

LKI

Product Code Name

Antisera, Fluorescent, Chlamydia Spp.

Public Device Record Key

e3b4a928-f6b3-4f02-abcf-9ceb913d170c

Public Version Date

March 04, 2020

Public Version Number

4

DI Record Publish Date

September 12, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-