Mycoplasma pneumoniae IgG Control - Bion Enterprises, Ltd.

Duns Number:024824641

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More Product Details

Catalog Number

MPG-1220

Brand Name

Mycoplasma pneumoniae IgG Control

Version/Model Number

MPG-1220

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

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 Details

Product Code

LQG

Product Code Name

Dna-Reagents, Mycoplasma Spp.

Device Record Status

Public Device Record Key

4c31bc78-c5b5-48d6-9527-b055ebbe8fcd

Public Version Date

March 04, 2020

Public Version Number

3

DI Record Publish Date

September 12, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BION ENTERPRISES, LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 68
2 A medical device with a moderate to high risk that requires special controls. 38