FDA.reportPublic FDA data

Beckman Coulter® PK® Systems Control

Primary DI
23661562173178
Brand
Beckman Coulter® PK® Systems Control
Company
DIAGAST
Model
17317
Catalog number
17317
Device description
Blood Grouping Reagent Control, formulated for Automated Systems, Beckman Coulter® PK® System
Published
2016-01-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
BK0600240

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK0600240

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
23661562173178PrimaryGS10
13661562173171Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2366156217317823661562173178
1366156217317113661562173171

GMDN Terms#

Term, Definition table
TermDefinition
Antisera matrix (non-reactive) IVD, controlA material consisting of antisera matrix but containing no active immunoglobulins that is intended be used as a negative control to verify the performance of an assay when testing a clinical specimen for red blood cell antigens.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-447-5852xxx@xx.xx

Regulatory Flags#

DUNS number
381527001
Device count
10
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
23661562173192Beckman Coulter® PK® Systems Anti-e (P3GD512+MS63)17319173192015-09-04
23661562173307Beckman Coulter® PK® Systems Bromelin17330173302015-09-18
23661562105469Anti-Human Globulin Anti-IgG,-C3d, polyspecific - Green2105462105462018-05-01
23661562105476Anti-Human Globulin Anti-IgG - Green2105472105472018-05-01
23661562105490Anti-Human Globulin Anti-IgG - Clear2105492105492018-05-01
23661562105506Anti-Human Globulin Anti-IgG,-C3d, polyspecific - Clear2105502105502018-05-01
23661562495584Beckman Coulter® PK® Systems Anti-e (P3GD512+MS16+MS21+MS63)B49558B495582020-10-20
23661562105209Anti-A (AB01)2105202105202018-05-01
23661562105216Anti-B (AB02)2105212105212018-05-01
23661562105223Anti-A,B (AB03)2105222105222018-05-01
23661562105247Anti-D (RH1) IgG2105242105242018-05-01
23661562105254Anti-D (RH1) IgM2105252105252018-05-01
23661562105278Anti-C (RH2)2105272105272018-05-01
23661562105285Anti-c (RH4)2105282105282018-05-01
23661562105292Anti-E (RH3)2105292105292018-05-01
23661562105308Anti-e (RH5)2105302102302018-05-01
23661562105315Anti-Fya (FY1)2105312105312018-05-01
23661562105322Anti-Fyb (FY2)2105322105322018-05-01
23661562105339Anti-K (KEL1)2105332105332018-05-01
23661562105346Anti-Jka (JK1)2105342105342018-05-01

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