RAMP® 1 Clinical Reader System - Response Biomedical Corp

Duns Number:248609018

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More Product Details

Catalog Number

-

Brand Name

RAMP® 1 Clinical Reader System

Version/Model Number

C1100

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

-

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

KHO

Product Code Name

Fluorometer, For Clinical Use

Device Record Status

Public Device Record Key

586951eb-3bb9-4ea3-a0de-54fe90db1800

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 31, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"RESPONSE BIOMEDICAL CORP" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 5