FDA.reportPublic FDA data

COULTER AcT

Primary DI
15099590639426
Brand
COULTER AcT
Company
Beckman Coulter, Inc.
Model
5diff
Catalog number
7547175
Device description
COULTER AcT 5diff Cal Calibrator
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
KRXCalibrator For Cell Indices

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRXCalibrator For Cell IndicesHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K912357000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K9123570003K-CAL HEMATOLOGY CALIBRATOR/MULTIPLER&D Systems, Inc.1991-07-09KRX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15099590639426PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1509959063942615099590639426

GMDN Terms#

Term, Definition table
TermDefinition
Full blood count IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative determination of one or multiple whole blood cell parameters in a clinical specimen [also known as complete blood count (CBC)]. Test components may include white cell count and differential, red cell count and calculation of red cell parameters and/or platelet count.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008254708
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15099590799250MicroScanV5.03 PU11D233542025-12-08
15099590807146MicroScanV5.03 DD07ED336042025-12-08
15099590799243MicroScanV5.03 PU11ED233522025-12-08
15099590807696UniCel DxH 900 COULTER Cellular Analysis System (Rebuilt by Beckman Coulter)D30863D308632026-05-19
15099590806323Access anti-HBc IgM D22920D229202026-05-04
15099590806330Access anti-HBc IgM CalibratorD22921D229212026-05-04
15099590806347Access anti-HBc IgM QCD22922D229222026-05-04
15099590806446Access anti-HAV IgMD25834D258342026-04-23
15099590806453Access anti-HAV IgM CalibratorD25835D258352026-04-23
15099590806460Access anti-HAV IgM QCD25836D258362026-04-23
15099590233501Synchron4725004725002016-08-24
15099590786533Access BNP IID06227D062272026-03-30
15099590806293Hepatitis B Virus core Total AntibodyD22917D229172026-03-30
15099590806309ACCESS anti-HBc Total CALIBRATORD22918D229182026-03-30
15099590806316ACCESS anti-HBc Total QCD22919D229192026-03-30
15099590572822Cytomics FC500UPS (MPL)6265542016-09-23
15099590572839Cytomics FC500UPS (CXP)6265532016-09-23
15099590736002Access PCTC53987C539872023-05-05
15099590806255ACCESS HBsAgD229132026-01-16
15099590806262ACCESS HBsAg ConfirmatoryD229142026-01-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00815762023446Research and Diagnostic SystemsRESEARCH AND DIAGNOSTIC SYSTEMS, INC.KRX2025-12-01
00815762023453Research and Diagnostic SystemsRESEARCH AND DIAGNOSTIC SYSTEMS, INC.KRX2025-12-01
06936415992927SC-CAL PLUSShenzhen Mindray Bio-Medical Electronics Co., Ltd.KRX2025-01-17
00380740151294AlinityAbbott GmbHKRX2023-11-16
14987562460332XN CALSYSMEX CORPORATIONKRX2017-10-06
14987562460356XN CAL PFSYSMEX CORPORATIONKRX2017-10-06
14987562460592X-CAL CalibratorSYSMEX CORPORATIONKRX2017-10-06
D757U2260K1One Step Plus KITBISCO INC.KRX2017-06-12
06944904084152SC-CAL PLUS CalibratorShenzhen Mindray Bio-Medical Electronics Co., Ltd.KRX2016-09-23
20844509000314Cal-Chex A Plus STRECK, INC.KRX2016-09-16
30844509000311Cal-Chex A Plus STRECK, INC.KRX2016-09-16
40844509000318Cal-Chex A PlusSTRECK, INC.KRX2016-09-16
00817274020258Drew ScientificDREW SCIENTIFIC, INC.KRX2016-09-09
00380740119843CELL-DYNABBOTT LABORATORIESKRX2016-09-09
00812137010254CDS-LTX CONTROLCLINICAL DIAGNOSTIC SOLUTIONS, INC.KRX2016-09-08
00856605006004MINOCALHORIBA INSTRUMENTS INCORPORATEDKRX2016-08-10
00856605006103MINOCALHORIBA INSTRUMENTS INCORPORATEDKRX2016-08-10
14987562460325XN CALSYSMEX CORPORATIONKRX2016-08-04
14987562460349XN CAL PFSYSMEX CORPORATIONKRX2016-08-04
14987562460585X-CAL CalibratorSYSMEX CORPORATIONKRX2016-08-04
10815762020473Research and Diagnostic SystemsRESEARCH AND DIAGNOSTIC SYSTEMS, INC.KRX2016-07-29
10815762020503Research and Diagnostic SystemsRESEARCH AND DIAGNOSTIC SYSTEMS, INC.KRX2016-07-29
10815762020541Research and Diagnostic SystemsRESEARCH AND DIAGNOSTIC SYSTEMS, INC.KRX2016-07-29
10815762020930Research and Diagnostic SystemsRESEARCH AND DIAGNOSTIC SYSTEMS, INC.KRX2016-07-29
10815762021166Research and Diagnostic SystemsRESEARCH AND DIAGNOSTIC SYSTEMS, INC.KRX2016-07-29
20815762020470Research and Diagnostic SystemsRESEARCH AND DIAGNOSTIC SYSTEMS, INC.KRX2016-07-29
20815762020937Research and Diagnostic SystemsRESEARCH AND DIAGNOSTIC SYSTEMS, INC.KRX2016-07-29
30815762020477Research and Diagnostic SystemsRESEARCH AND DIAGNOSTIC SYSTEMS, INC.KRX2016-07-29
00815762020483Research and Diagnostic SystemsRESEARCH AND DIAGNOSTIC SYSTEMS, INC.KRX2016-07-29
00380740017071CELL-DYNABBOTT LABORATORIESKRX2016-06-06