FDA.reportPublic FDA data

Capture-R Ready-Screen (3)

Primary DI
10888234002369
Brand
Capture-R Ready-Screen (3)
Company
IMMUCOR, INC.
Model
0066816
Catalog number
0066816
Device description
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.
Published
2018-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KSZSystem, Test, Automated Blood Grouping And Antibody

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KSZSystem, Test, Automated Blood Grouping And AntibodyHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888234002369PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088823400236910888234002369

GMDN Terms#

Term, Definition table
TermDefinition
Solid phase red blood cell adherence antibody/antigen IVDA microplate or test strip of protein-activated wells intended to be used in immunohaematological testing of a clinical specimen for the detection and/or identification of red blood cell antibodies or antigens, using a solid phase red blood cell adherence method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature1 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-855-466-8267tech_support@immucor.com

Regulatory Flags#

DUNS number
061446282
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10888234002291Capture LISS006690800669082022-09-03
10888234001027H.P.C. (Human Platelet Concentrate)005732000573202016-04-18
10888234002475ImmuLINK00303112024-12-05
10888234000495Red Blood Cell (RBC) Storage Solution000503600050362016-04-15
10888234001065Specimen Diluent006605200660522016-04-18
10888234001072Specimen Diluent006605300660532016-04-18
10888234001041Galileo Neo006459900645992016-04-18
10888234001584Galileo Echo008700000870002016-04-18
10888234001591CMT Plates008900000890002016-04-18
10888234002321NEO Iris006459700645972018-12-10
10888234002338Echo Lumena008699800869982018-06-01
10888234001546Capture-R Positive Control Serum (Weak), Capture-R Negative Control Serum006690200669022022-09-03
10888234001553Capture-R Select006690300669032022-09-03
10888234001560Capture-P006690400669042022-09-03
10888234001577Capture-P Positive Control Serum (Weak), Capture-P Negative Control Serum006690500669052022-09-03
10888234002307Capture-R Ready Indicator Red Cells006690700669072022-09-03
10888234002314Capture-P Indicator Red Cells006690600669062022-09-03
10888234001522Referencells006690000669002022-08-03
10888234001539Capture-R Ready-Screen 3006690100669012022-08-01
10888234002239Gamma-Clone Anti-Fya (Monoclonal) Blood Grouping Reagent10 mL size vial / 5mL fill volume00664302022-04-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05713494002829ELDON SCHOOL KIT SKA 2511-30Eldon Biologicals A/SKSZ2026-05-19
05713494002836ELDON SCHOOL KIT SK 2511-30Eldon Biologicals A/SKSZ2026-05-19
05713494002843ELDON SCHOOL KIT SKA 2521-25Eldon Biologicals A/SKSZ2026-05-19
05713494002683ELDON MILITARY KIT MKA 2521-25Eldon Biologicals A/SKSZ2024-07-05
05713494002690ONE MAN KIT OKA 2511-1Eldon Biologicals A/SKSZ2024-07-05
05713494002638ELDON HOME KIT HKA 2511-1Eldon Biologicals A/SKSZ2023-03-08
05713494002409ELDON HOME KIT HKA 2511-1Eldon Biologicals A/SKSZ2022-11-28
05713494002546ELDON SCHOOL KIT SKA 2521-25Eldon Biologicals A/SKSZ2022-10-04
10888234001553Capture-R SelectIMMUCOR, INC.KSZ2022-09-03
03610522055685IH-Card ABO NeutralBio-Rad Medical Diagnostics GmbHKSZ2022-03-09
05713494002287ELDON SCHOOL KIT SKA 2511-30Eldon Biologicals A/SKSZ2021-11-11
05713494002270ELDON HOME KIT HKA 2511-1Eldon Biologicals A/SKSZ2021-09-16
05713494002225ELDON SCHOOL KIT SKA 2521-25Eldon Biologicals A/SKSZ2021-05-31
05713494001990ELDON HOME KIT HKA 2511-1Eldon Biologicals A/SKSZ2021-04-27
10758750032846ORTHOORTHO-CLINICAL DIAGNOSTICS, INC.KSZ2021-04-07
03610522123919IH-Com V5.2Bio-Rad Medical Diagnostics GmbHKSZ2021-02-18
05713494001976ELDONBOX 2521-100 100 ELDONCARD 2521Eldon Biologicals A/SKSZ2021-02-04
05713494000313ELDONBOX 2521-100 100 ELDONCARD 2521Eldon Biologicals A/SKSZ2021-02-04
05713494001808ELDON SCHOOL KIT SK 2511-30Eldon Biologicals A/SKSZ2020-12-12
05713494001952ELDON HOME KIT HKA 2511-2Eldon Biologicals A/SKSZ2020-12-12
05713494001969ELDON HOME KIT HKA 2511-5Eldon Biologicals A/SKSZ2020-12-12
05713494000306ELDON HOME KIT HKA 2511-5Eldon Biologicals A/SKSZ2020-12-12
05060496770066Ortho ConnectBIOMEDICAL DATA SOLUTIONS LIMITEDKSZ2020-11-18
08437014205008DG Gel 8 NeutralDIAGNOSTIC GRIFOLS SAKSZ2020-11-16
05713494001785ELDONBOX 2511-100 100 ELDONCARD 2511Eldon Biologicals A/SKSZ2020-11-04
05713494001792ELDON SCHOOL KIT SKA 2511-30Eldon Biologicals A/SKSZ2020-11-04
05713494001761ELDON HOME KIT HKA 2511-1Eldon Biologicals A/SKSZ2020-11-04
05713494001778ELDON HOME KIT HKA 2511-1Eldon Biologicals A/SKSZ2020-11-04
05713494001754ELDON HOME KIT HKA 2511-1Eldon Biologicals A/SKSZ2020-08-31
14987666543344PK7400Beckman Coulter, Inc.KSZ2020-07-06