FDA.reportPublic FDA data

MicroScan

Primary DI
15099590693404
Brand
MicroScan
Company
Beckman Coulter, Inc.
Model
B1020-100B
Device description
Detect Neg MIC Panel Type 1
Published
2017-08-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
JWYManual Antimicrobial Susceptibility Test Systems
OTTResearch Use Only/Microbiology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JWYManual Antimicrobial Susceptibility Test SystemsMicrobiology2
OTTResearch Use Only/MicrobiologyUnknownN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15099590693404PrimaryGS10
05099590693407Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1509959069340415099590693404
05099590693407050995906934075099590693407

GMDN Terms#

Term, Definition table
TermDefinition
General-microorganism antimicrobial susceptibility culture medium IVDA non-selective culture medium intended to be used to perform diagnostic antimicrobial susceptibility testing on general microorganisms isolated from a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008254708
Device count
20
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
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
15099590806279Access HBsAg CALIBRATORD229152026-01-16
15099590806286ACCESS HBsAg QCD229162026-01-16
15099590806415ACCESS anti-HAVD258312026-01-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08058951161426Liofilchem Mic Test Strip (MTS)LIOFILCHEM SRLJWY2026-01-12
08058951161433Liofilchem Mic Test Strip (MTS)LIOFILCHEM SRLJWY2026-01-12
15099590798970MicroScanBeckman Coulter, Inc.JWY2025-12-08
15099590798987MicroScanBeckman Coulter, Inc.JWY2025-12-08
15099590798994MicroScanBeckman Coulter, Inc.JWY2025-12-08
15099590799007MicroScanBeckman Coulter, Inc.JWY2025-12-08
15099590799014MicroScanBeckman Coulter, Inc.JWY2025-12-08
15099590799021MicroScanBeckman Coulter, Inc.JWY2025-12-08
08058951161266Liofilchem Mic Test Strip (MTS)LIOFILCHEM SRLJWY2025-11-03
08058951161273Liofilchem Mic Test Strip (MTS)LIOFILCHEM SRLJWY2025-11-03
08058951161310Liofilchem Antibiotic DiscLIOFILCHEM SRLJWY2025-11-03
08058951161327Liofilchem Antibiotic DiscLIOFILCHEM SRLJWY2025-11-03
08055182878574Liofilchem Antibiotic DiscLIOFILCHEM SRLJWY2025-07-15
08055182873371Liofilchem MTS (MIC Test Strip)LIOFILCHEM SRLJWY2025-03-19
18055182873361Liofilchem MTS (MIC Test Strip)LIOFILCHEM SRLJWY2025-03-19
00848838036835SENSITITRE YEASTONE SUSCEPTIBILITY PLATESREMEL, INC.JWY2023-06-20
00848838074530Sensititire® OptiRead™REMEL, INC.JWY2023-06-20
00848838097409THE SENSITITRE AIMREMEL, INC.JWY2023-06-20
15099590765361MicroScanBeckman Coulter, Inc.JWY2022-08-01
15099590765378MicroScanBeckman Coulter, Inc.JWY2022-08-01
15099590765385MicroScanBeckman Coulter, Inc.JWY2022-08-01
18055182870124Liofilchem MTS (MIC Test Strip)LIOFILCHEM SRLJWY2022-01-28
18055182870155Liofilchem MTS (MIC Test Strip)LIOFILCHEM SRLJWY2022-01-28
18055182870186Liofilchem MTS (MIC Test Strip)LIOFILCHEM SRLJWY2022-01-28
18055182870216Liofilchem MTS (MIC Test Strip)LIOFILCHEM SRLJWY2022-01-28
18055182870247Liofilchem MTS (MIC Test Strip)LIOFILCHEM SRLJWY2022-01-28
18055182870278Liofilchem MTS (MIC Test Strip)LIOFILCHEM SRLJWY2022-01-28
18055182870308Liofilchem MTS (MIC Test Strip)LIOFILCHEM SRLJWY2022-01-28
18055182870605Liofilchem MTS (MIC Test Strip)LIOFILCHEM SRLJWY2022-01-28
18055182871145Liofilchem MTS (MIC Test Strip)LIOFILCHEM SRLJWY2022-01-28