PreciControl HIV; HIV-2 + GrpO - Roche Diagnostics GmbH

Duns Number:315028860

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More Product Details

Catalog Number

06924115160

Brand Name

PreciControl HIV; HIV-2 + GrpO

Version/Model Number

06924115160

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

BP160050,BP160050,BP190403

Product Code Details

Product Code

MZF

Product Code Name

Test, Hiv Detection

Device Record Status

Public Device Record Key

d9a21aef-ceb3-48a4-9d2a-9cd40f221339

Public Version Date

September 20, 2021

Public Version Number

5

DI Record Publish Date

July 31, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ROCHE DIAGNOSTICS GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 289
2 A medical device with a moderate to high risk that requires special controls. 760
3 A medical device with high risk that requires premarket approval 63
U Unclassified 4