Elecsys HBsAg Confirmatory Test - HBsAg Confirmatory Test Elecsys cobas e V2 - Roche Diagnostics GmbH

Duns Number:315028860

Device Description: HBsAg Confirmatory Test Elecsys cobas e V2

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More Product Details

Catalog Number

09127127190

Brand Name

Elecsys HBsAg Confirmatory Test

Version/Model Number

09127127190

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

P160019

Product Code Details

Product Code

LOM

Product Code Name

Test, hepatitis b (b core, be antigen, be antibody, b core igm)

Device Record Status

Public Device Record Key

b3c32945-669c-4fa3-b42a-9fd1253f6f5a

Public Version Date

February 03, 2022

Public Version Number

1

DI Record Publish Date

January 26, 2022

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