Capture-R Ready-Screen (3) - Capture-R Ready-Screen (3) is used in the - IMMUCOR, INC.

Duns Number:061446282

Device Description: Capture-R Ready-Screen (3) is used in the detection of unexpected IgG antibodies to red bl Capture-R Ready-Screen (3) is used in the detection of unexpected IgG antibodies to red blood cells by manual, semi-automated or automated solid phase red blood cell adherence methods. This product contains three (3) test wells coated with red blood cell membranes from three (3) group O donors, as well as a positive control well, which all make up one (1) test of four (4) wells. Each strip consists of two antibody screens, i.e. two (2) sets of four (4) wells. Each microplate contains twelve (12) strips. Each microplate is packaged into a pouch. This particular product code package configuration is made up of five (5) microplates of the identical product, and the identical lot number, placed into the one (1) single box. The antigens Mia and Mur are represented with this product version.

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More Product Details

Catalog Number

0066816

Brand Name

Capture-R Ready-Screen (3)

Version/Model Number

0066816

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

-

Product Code Details

Product Code

KSZ

Product Code Name

System, Test, Automated Blood Grouping And Antibody

Device Record Status

Public Device Record Key

2952ce7b-8d94-42bf-9401-678db5f6705a

Public Version Date

July 08, 2021

Public Version Number

2

DI Record Publish Date

September 12, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"IMMUCOR, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 18
2 A medical device with a moderate to high risk that requires special controls. 58
U Unclassified 3