Catalog Number

6L18-80

Brand Name

RealTime

Version/Model Number

6L18-80

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

BP060002,BP060002,BP060002,BP060002,BP060002,BP060002,BP060002,BP060002,BP060002,BP060002,BP060002,BP060002,BP060002,BP060002,BP060002,BP060002,BP060002,BP060002,BP060002,BP060002,BP060002,BP060002,BP060002,BP060002,BP060002,BP060002,BP060002,BP060002,BP060002,BP060002,BP060002

Product Code

MZF

Product Code Name

Test, hiv detection

Public Device Record Key

ffc1fbef-e794-46ab-ade5-ed6de9d3fd32

Public Version Date

November 26, 2019

Public Version Number

4

DI Record Publish Date

July 01, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-