FDA.reportPublic FDA data

MicroScan

Primary DI
05099590799024
Brand
MicroScan
Company
Beckman Coulter, Inc.
Model
D18448
Device description
MicroScan Pos MIC 41
Published
2025-12-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
JWYManual Antimicrobial Susceptibility Test Systems

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JWYManual Antimicrobial Susceptibility Test SystemsMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K003619000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K003619000DRIED GRAM-POSITIVE MIC/COMBO PANELSDade Microscan, Inc.2001-01-09LTT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15099590799021PrimaryGS10
05099590799024Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1509959079902115099590799021
05099590799024050995907990245099590799024

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008254708
Device count
20
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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