CON-Trate Bulk Tubes & Caps - The Meridian CON-Trate system is a complete - MERIDIAN BIOSCIENCE, INC.

Duns Number:092815364

Device Description: The Meridian CON-Trate system is a complete system for concentrating and recovering helmin The Meridian CON-Trate system is a complete system for concentrating and recovering helminth eggs, larvae, and protozoan cysts from feces.

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

800400

Brand Name

CON-Trate Bulk Tubes & Caps

Version/Model Number

800400

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

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 Details

Product Code

LKS

Product Code Name

Device, Parasite Concentration

Device Record Status

Public Device Record Key

5aad369a-61da-43a7-b0eb-1353a9814719

Public Version Date

September 29, 2020

Public Version Number

1

DI Record Publish Date

September 21, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MERIDIAN BIOSCIENCE, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 149
2 A medical device with a moderate to high risk that requires special controls. 46
3 A medical device with high risk that requires premarket approval 1