Biotrin Parvovirus B19 IgM EIA - DIASORIN SPA

Duns Number:630822989

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More Product Details

Catalog Number

-

Brand Name

Biotrin Parvovirus B19 IgM EIA

Version/Model Number

V619IMUS

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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

-

Product Code Details

Product Code

-

Product Code Name

-

Device Record Status

Public Device Record Key

65fca112-be9b-4e17-bd68-ab09ce3ab137

Public Version Date

December 05, 2019

Public Version Number

1

DI Record Publish Date

November 27, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DIASORIN SPA" Characteristics
Device Class Device Class Description No of Devices
3 A medical device with high risk that requires premarket approval 3