FDA.reportPublic FDA data

DAT Positive Control Cell

Primary DI
10888234001102
Brand
DAT Positive Control Cell
Company
IMMUCOR, INC.
Model
0066122
Catalog number
0066122
Device description
DAT Positive Control Cell is designed to be used only with the Immucor automated instruments. DAT Positive Control Cells are IgG-coated red blood cells used as a control to confirm the validity of the DAT assay and other assays utilizing the direct antiglobulin test on Immucor automated instruments. This product is the one (1) vial configuration.
Published
2016-04-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KSFKit, Quality Control For Blood Banking Reagents

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KSFKit, Quality Control For Blood Banking ReagentsHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK1100500

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK1100500

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888234001102PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088823400110210888234001102

GMDN Terms#

Term, Definition table
TermDefinition
Multiple immunohaematology test IVD, controlA collection of reagent red blood cells and/or immunoglobulins directed at red blood cell antigens that are supplied together and intended to be used when testing a clinical specimen to verify the performance of multiple immunohaematological tests.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature1 Degrees Celsius10 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
Contains natural rubber latex
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
05060242473067Ortho™ Confidence Manual SystemALBA BIOSCIENCE LIMITEDKSF2026-03-12
M220762002Pro AdvantageNATIONAL DISTRIBUTION & CONTRACTING, INC.KSF2025-09-11
M220762003Pro AdvantageNATIONAL DISTRIBUTION & CONTRACTING, INC.KSF2025-09-11
04065266566086ORTHO Daily QC Simulated Whole Blood Quality Control KitMILLIPORE (U.K.) LIMITEDKSF2024-04-10
10888234002307Capture-R Ready Indicator Red CellsIMMUCOR, INC.KSF2022-09-03
05060242472473ALBAcheck - BGS Monoclonal ControlALBA BIOSCIENCE LIMITEDKSF2020-06-19
05060242472459ALBAcheck - BGS Monoclonal ControlALBA BIOSCIENCE LIMITEDKSF2020-06-19
05060242472329ALBAcyte IgG Sensitized Red Blood Cells IIALBA BIOSCIENCE LIMITEDKSF2019-05-10
05060242472336ALBAcyte IgG Sensitized Red Blood Cells IIALBA BIOSCIENCE LIMITEDKSF2019-05-10
23661562105438Neg ControlDIAGASTKSF2018-05-01
07611969952342IH-Internal QCBio-Rad Medical Diagnostics GmbHKSF2018-04-05
07611969952335IH-Basic QCBio-Rad Medical Diagnostics GmbHKSF2018-02-28
00816784020871ACCURUN®Lgc Clinical Diagnostics, Inc.KSF2017-12-01
00816784020888ACCURUN®Lgc Clinical Diagnostics, Inc.KSF2017-12-01
00858352006122MQCHEMO BIOSCIENCE INCKSF2017-06-28
00858352006139MQC-CATHEMO BIOSCIENCE INCKSF2017-06-26
05060242470943AlbaQ-Chek® ALBA BIOSCIENCE LIMITEDKSF2017-03-29
00816784020772ACCURUN®Lgc Clinical Diagnostics, Inc.KSF2017-03-09
07611969952212IH-Card ControlBio-Rad Medical Diagnostics GmbHKSF2017-01-20
00858352006009Hemo-QCHEMO BIOSCIENCE INCKSF2016-10-20
00858352006016C3 Control CellsHEMO BIOSCIENCE INCKSF2016-09-29
00816784020437ACCURUN®Lgc Clinical Diagnostics, Inc.KSF2016-09-27
05060242471162ALBAcyte IgG Sensitized Red Blood CellsALBA BIOSCIENCE LIMITEDKSF2016-09-24
00816784020024ACCURUN®Lgc Clinical Diagnostics, Inc.KSF2016-09-24
00816784020031ACCURUN®Lgc Clinical Diagnostics, Inc.KSF2016-09-24
00816784020048ACCURUN®Lgc Clinical Diagnostics, Inc.KSF2016-09-24
00816784020055ACCURUN®Lgc Clinical Diagnostics, Inc.KSF2016-09-24
00816784020062ACCURUN®Lgc Clinical Diagnostics, Inc.KSF2016-09-24
00816784020123ACCURUN®Lgc Clinical Diagnostics, Inc.KSF2016-09-24
00816784020215ACCURUN®Lgc Clinical Diagnostics, Inc.KSF2016-09-24