ALBAlect Anti-A1 Dolichos biflorus Blood Grouping Lectin - For the in vitro detection and identification of - ALBA BIOSCIENCE LIMITED

Duns Number:516536641

Device Description: For the in vitro detection and identification of human A1 red blood cellls

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More Product Details

Catalog Number

-

Brand Name

ALBAlect Anti-A1 Dolichos biflorus Blood Grouping Lectin

Version/Model Number

Z241U

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

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 Details

Product Code

KSI

Product Code Name

Lectins And Protectins

Device Record Status

Public Device Record Key

854261b4-5e1f-4af8-a6bb-afdc04ca0233

Public Version Date

March 31, 2022

Public Version Number

4

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ALBA BIOSCIENCE LIMITED" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 8