Catalog Number

MP-1206

Brand Name

Mycoplasma pneumoniae Antigen Substrate, 6 wells, For IFA Test System

Version/Model Number

MP-1206

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 02, 2016

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

-

Product Code

LQG

Product Code Name

Dna-Reagents, Mycoplasma Spp.

Public Device Record Key

2604c4f0-9809-468c-b099-7e3685d43e65

Public Version Date

March 04, 2020

Public Version Number

3

DI Record Publish Date

August 02, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-