FDA.reportPublic FDA data

Beckman Coulter PK TP System Control Set

Primary DI
00850212007041
Brand
Beckman Coulter PK TP System Control Set
Company
FUJIREBIO DIAGNOSTICS, INC.
Model
PH3502
Published
2016-09-16
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
KSZSystem, Test, Automated Blood Grouping And Antibody

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KSFKit, Quality Control For Blood Banking ReagentsHematology2
KSZSystem, Test, Automated Blood Grouping And AntibodyHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK0600620

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK0600620

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850212007041PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850212007041008502120070418502120070410850212007041

GMDN Terms#

Term, Definition table
TermDefinition
Treponema pallidum total antibody IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of total antibodies to Treponema pallidum bacteria in a clinical specimen.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature2 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-447-5852xx@xx.xx
800-223-0125xx@xx.com

Regulatory Flags#

DUNS number
079291908
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00869164000086Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio CL00732024-11-04
00850212007058Beckman Coulter PK CMV-PA SYSTEM Control Set240226PA23022016-09-16
00869164000055Serodia TP-PA Kits2349522023-12-06
00869164000062Serodia TP-PA Kits2349762023-12-06
00869164000079Emit Cyclosporine Sample40080862023-12-06
00869164000000MESOMARK801-9052014-09-17
00869164000048Lumipulse G B-Amyloid Ratio (1-42/1-40) Calculator ToolCL00122022-11-10
00850212007096Lumipulse G Wash Solution40082482017-10-06
00869164000017Lumipulse G ROMACL00042016-09-19
00869164000024ROMA404-10US2016-09-19
00850212007072Fertility Control 21301622020-12-07
00850212007089Vitamin D Control21301662020-07-14
00850212007003FITC Anti-Rabies Monoclonal Globulin800-0922016-09-16
00850212007010Serodia TP-PA16262016-09-16
00850212007027Serodia TP-PA16332016-09-16
00850212007034Vitamin D Control21301522016-09-16
00850212007065Syphilis Control21301702017-06-23

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
05060242473067Ortho™ Confidence Manual SystemALBA BIOSCIENCE LIMITEDKSF2026-03-12
M220762002Pro AdvantageNATIONAL DISTRIBUTION & CONTRACTING, INC.KSF2025-09-11
M220762003Pro AdvantageNATIONAL DISTRIBUTION & CONTRACTING, INC.KSF2025-09-11
05713494002683ELDON MILITARY KIT MKA 2521-25Eldon Biologicals A/SKSZ2024-07-05
05713494002690ONE MAN KIT OKA 2511-1Eldon Biologicals A/SKSZ2024-07-05
04065266566086ORTHO Daily QC Simulated Whole Blood Quality Control KitMILLIPORE (U.K.) LIMITEDKSF2024-04-10
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
10888234002307Capture-R Ready Indicator Red CellsIMMUCOR, INC.KSF2022-09-03
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