Catalog Number

-

Brand Name

Maxim HIV-1 Urine EIA

Version/Model Number

700000

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

MZF

Product Code Name

Test, Hiv Detection

Public Device Record Key

037255f0-1182-40b3-ac2a-c7055e1b62e4

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

June 19, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-