Unsaturated Iron-Binding Capacity - Roche Diagnostics GmbH

Duns Number:315028860

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More Product Details

Catalog Number

08058776190

Brand Name

Unsaturated Iron-Binding Capacity

Version/Model Number

08058776190

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 28, 2020

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

-

Product Code Details

Product Code

JMO

Product Code Name

Ferrozine (colorimetric) iron binding capacity

Device Record Status

Public Device Record Key

06678a5f-2198-469c-8cee-3cbaaebbef1c

Public Version Date

November 11, 2020

Public Version Number

2

DI Record Publish Date

March 05, 2020

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