FDA.reportPublic FDA data

MicroScan

Primary DI
15099590798970
Brand
MicroScan
Company
Beckman Coulter, Inc.
Model
D18443
Catalog number
D18443
Device description
MicroScan Neg MIC 65
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
K032706000
K050585000
K061687000
K162740000
K172255000
K172337000
K183127000
K192355000
K193358000
K193536000
K201423000
K202343000
K243804000
K250084000
K861584000
K862140000
K863776000
K883076000
K926545000
K955910000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K032706000MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS WITH ERTAPENEM (0.002-32 MCG/MLDade Behring, Inc.2004-02-10JWY
K050585000MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS AMOXICILLIN/K. CLAVULANATEDade Behring, Inc.2005-03-18LRG
K061687000MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELSDade Behring, Inc.2006-07-21JWY
K162740000MicroScan Dried Gram-Negative MIC/Combo Panels with Imipenem (0.25 - 8 ug/mL)Beckman Coulter, Inc.2017-03-21LTT
K172255000MicroScan Dried Gram Negative MIC/Combo Panels with Ceftolozane/tazobactam (0.25/4 - 16/4 ug/mL)Beckman Coulter, Inc.2017-12-01LTT
K172337000MicroScan Dried Gram Negative MIC/Combo Panels with Ceftazidime/Avibactam (0.25/4 - 64/4 ug/mL)Beckman Coulter, Inc.2017-12-15LTT
K183127000MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem/Vaborbactam (0.03/8-64/8ug/mL)Beckman Coulter, Inc.2019-02-12LTT
K192355000MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32ug/mL)Beckman Coulter, Inc.2019-11-14JWY
K193358000MicroScan Dried Gram-Negative MIC/Combo Panels with Levofloxacin (Lvx) (0.008-16ug/mL)Beckman Coulter, Inc.2020-03-03LTT
K193536000MicroScan Dried Gram Negative MIC/Combo Panels with Ciprofloxacin (Cp) (0.004 - 8µg/mL)Beckman Coulter, Inc.2020-03-18LTT
K201423000MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32 µg/mL)Beckman Coulter, Inc.2020-06-29LTT
K202343000MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 µg/mL )Beckman Coulter, Inc.2020-11-16LTT
K243804000MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL) (MicroScan)Beckman Coulter, Inc.2025-08-20LTT
K250084000MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/mL)Beckman Coulter, Inc.2025-07-18LTT
K861584000GRAM NEGATIVE COMBO PANEL TYPE 3American Micro Scan1986-06-17JWY
K862140000MICRODILUTION PANELSAmerican Micro Scan1986-07-16JWY
K863776000MICRODILUTION MIC PANELSAmerican Micro Scan1987-02-02JWY
K883076000GRAM NEGATIVE & GRAM POSITIVE MIC/COMBO PANELSBaxter Healthcare Corp1988-09-07JWY
K926545000DRIED GRAM-NEGATIVE MIC/COMBO PANELSBaxter Diagnostics, Inc.1993-03-26JWY
K955910000DRIED GRAM-NEGATIVE MIC/COMBO PANELSDade Microscan, Inc.1996-02-23JWY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15099590798970PrimaryGS10
05099590798973Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1509959079897015099590798970
05099590798973050995907989735099590798973

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
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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