FDA.reportPublic FDA data

MicroScan

Primary DI
15099590655792
Brand
MicroScan
Company
Beckman Coulter, Inc.
Model
B1015-3
Device description
MicroScan 0.05N Sodium Hydroxide - 30ml
Published
2022-11-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JXBKit, Identification, Yeast

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JXBKit, Identification, YeastMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15099590655792PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1509959065579215099590655792

GMDN Terms#

Term, Definition table
TermDefinition
Multiple Candida/yeast species culture isolate identification IVD, kitA collection of reagents and other associated materials intended to be used for the differentiation and/or identification of one or multiple species of Candida and/or yeast isolated by culture from a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008254708
Device count
1
Premarket exempt
true
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
00848838058455Remel™ RapID™ ERIC™ (ELECTRONIC RAPID IDENTIFICATION COMPENDIUM)REMEL, INC.JXB2024-11-13
00848838022432BACTICARDREMEL, INC.JXB2022-12-23
15099590658106MicroScanBeckman Coulter, Inc.JXB2022-12-05
15099590655716MicroScanBeckman Coulter, Inc.JXB2022-11-15
15099590655839MicroScanBeckman Coulter, Inc.JXB2022-11-15
00848838058233Remel REMEL, INC.JXB2021-11-12
30848838058234Remel REMEL, INC.JXB2021-11-12
03848838058230Remel REMEL, INC.JXB2021-11-12
03573026529697VITEK® 2 YSTBIOMERIEUX , INC.JXB2020-06-02
03573026131937VITEK® 2 YSTBIOMERIEUX , INC.JXB2020-06-02
03573026048082API® 20 C AUXBIOMERIEUX SAJXB2020-04-10
03573026066383ID 32 CBIOMERIEUX SAJXB2020-04-10
00382904483166BD Phoenix™ YEAST IDBECTON, DICKINSON AND COMPANYJXB2018-05-25
30382904483167BD Phoenix™ Yeast IDBECTON, DICKINSON AND COMPANYJXB2018-05-25