FDA.reportPublic FDA data

MicroScan

Primary DI
15099590799021
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
Single use
true

Product Codes#

Code, Name table
CodeName
JWYManual Antimicrobial Susceptibility Test Systems
LRGInstrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
LTTPanels, Test, Susceptibility, Antimicrobial
LTWSusceptibility Test Cards, Antimicrobial

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JWYManual Antimicrobial Susceptibility Test SystemsMicrobiology2
LRGInstrument For Auto Reader & Interpretation Of Overnight Suscept. SystemsMicrobiology2
LTTPanels, Test, Susceptibility, AntimicrobialMicrobiology2
LTWSusceptibility Test Cards, AntimicrobialMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K003619000
K010418000
K020160000
K020162000
K050043000
K081013000
K081182000
K123933000
K131275000
K152346000
K250036000
K862140000
K870074000
K874876000
K934323000
K934458000
K945235000
K972688000
K993102000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K003619000DRIED GRAM-POSITIVE MIC/COMBO PANELSDade Microscan, Inc.2001-01-09LTT
K010418000DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELSDade Behring, Inc.2001-08-22LTT
K020160000DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH AMPICILLINDade Behring, Inc.2002-03-14LTT
K020162000DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH PENICILLINDade Behring, Inc.2002-03-14JWY
K050043000MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROMYCINDade Behring, Inc.2005-03-29LRG
K081013000MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL TEST CEFOXITIN SCREENSiemens Healthcare Diagnostics2008-09-08LRG
K081182000MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL TEST - INDUCIBLE CLINDAMYCINSiemens2008-08-08JWY
K123933000MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - CEFTAROLINESiemens Healthcare Diagnostics, Inc.2013-03-14LTT
K131275000MICROSCAN DRIED GRAM-POSTIVE MIC/COMBO PANELSSiemens Helathcare Diagnostics, Inc.2013-11-08LTT
K152346000MicroScan Dried Gram Positive MIC/Combo Panels - Vancomycin (0.25-64 ug/mL)Beckman Coulter, Inc.2015-09-16JWY
K250036000MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL)Beckman Coulter, Inc.2025-08-15LTT
K862140000MICRODILUTION PANELSAmerican Micro Scan1986-07-16JWY
K870074000GRAM NEGATIVE AND GRAM POSITIVE MIC/COMBO PANELSMicroscan Div. Baxter Healthcare Corp.1987-04-14JWY
K874876000GRAM - & GRAM + MIC/COMBO & BREAKPOINT/COMBO PANELBaxter Healthcare Corp1988-01-11JWY
K934323000DRIED GRAM-POSITIVE MIC/COMBO PANELS, AMP/EXT DILBaxter Diagnostics, Inc.1994-10-19JWY
K934458000DRIED GRAM-POSITIVE MIC/COMBO PANELSBaxter Diagnostics, Inc.1995-07-18JWY
K945235000DRIED GRAM-POSITIVE MIC/COMBO PANELSBaxter Diagnostics, Inc.1995-03-07LTT
K972688000MICROSCAN DRIED GRAM POSITIVE MIC/COMBO PANELS LEVOFLOXACINDade Microscan, Inc.1997-09-08JWY
K993102000DRIED GRAM-POSITIVE MIC/COMBO PANELSDade Microscan, Inc.1999-12-02LTT

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.

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
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
08055182872954Liofilchem MTS (MIC Test Strip)LIOFILCHEM SRLJWY2021-10-27
08055182872961Liofilchem MTS (MIC Test Strip)LIOFILCHEM SRLJWY2021-10-27
08055182872176Liofilchem MTS (MIC Test Strip)LIOFILCHEM SRLJWY2020-05-15
08055182872183Liofilchem MTS (MIC Test Strip)LIOFILCHEM SRLJWY2020-05-15
08055182871155Liofilchem Mic Test Strip (MTS)LIOFILCHEM SRLJWY2019-12-06
08055182871162Liofilchem Mic Test Strip (MTS)LIOFILCHEM SRLJWY2019-12-06
08055182872299Liofilchem MIC Test Strip (MTS)LIOFILCHEM SRLJWY2019-09-16
08055182872305Liofilchem Mic Test Strip (MTS)LIOFILCHEM SRLJWY2019-09-16
08055182873821Liofilchem MIC Test StripLIOFILCHEM SRLJWY2019-09-12
08055182873838Liofilchem MIC Test StripLIOFILCHEM SRLJWY2019-09-12
08055182872473Liofilchem MIC Test StripLIOFILCHEM SRLJWY2019-08-30
08055182872480Liofilchem MIC Test StripLIOFILCHEM SRLJWY2019-08-30
08055182870615Liofilchem MIC Test StripLIOFILCHEM SRLJWY2019-08-02
08055182870622Liofilchem MIC Test StripLIOFILCHEM SRLJWY2019-08-02
08055182871698Liofilchem Mic Test Strip (MTS)LIOFILCHEM SRLJWY2019-04-19
08055182871704Liofilchem Mic Test Strip (MTS)LIOFILCHEM SRLJWY2019-04-19
08055182872565Liofilchem Mic Test Strip (MTS)LIOFILCHEM SRLJWY2019-04-19
08055182872572Liofilchem Mic Test Strip (MTS)LIOFILCHEM SRLJWY2019-04-19
08055182873043Liofilchem Mic Test Strip (MTS)LIOFILCHEM SRLJWY2019-03-04
08055182873050Liofilchem Mic Test Strip (MTS)LIOFILCHEM SRLJWY2019-03-04
08055182872381Liofilchem Mic Test Strip (MTS)LIOFILCHEM SRLJWY2019-01-31
08055182872398Liofilchem Mic Test Strip (MTS)LIOFILCHEM SRLJWY2019-01-31