FDA.reportPublic FDA data

CHROMID® MRSA / CHROMID S. aureus

Primary DI
03573026552091
Brand
CHROMID® MRSA / CHROMID S. aureus
Company
BIOMERIEUX SA
Model
CHROMID® MRSA / CHROMID S. aureus
Device description
Chromogenic medium for the screening and qualitative detection of methicillin-resistant Staphylococcus aureus and selective isolation of staphylococci and the direct identification of S. aureus.
Published
2016-09-16
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
JSOCulture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JSOCulture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton AgarMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151688000
K162076000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151688000chromID MRSAbioMerieux, Inc.2016-03-11JSO
K162076000chromID MRSAbioMerieux, Inc.2016-10-25JSO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03573026420758PackageGS12In Commercial Distribution
03573026552091PrimaryGS10
03573026552107Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03573026420758035730264207583573026420758
03573026552091035730265520913573026552091
03573026552107035730265521073573026552107

GMDN Terms#

Term, Definition table
TermDefinition
Multiple formulation agar culture medium IVDA combination of two or more selective, differential and/or enriched agar culture media formulations separately contained within a single petri dish (commonly referred to as a split plate) or dip slide and intended to be used for the simultaneous growth, selective isolation and/or differentiation of microorganisms from a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Regulatory Flags#

DUNS number
276816717
Device count
10
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03573026064532VIDAS® Measles IgG302192019-08-30
03573026064518VIDAS® Varicella-Zoster IgG302172016-08-31
03573026610418VITEK®MSVITEKMS SW v1.0 / FlexPrep v1.02019-04-30
03573026644796VIDAS® Varicella-Zoster IgG30217-012026-01-19
03573026550523ETEST® Tigecycline (TGC)Etest® TIGECYCLINE2016-12-12
03573026584139ID color CatalaseID color Catalase2019-07-19
03573026092009ID color CatalaseID color Catalase2019-07-19
03573026559823THxID™ BRAF1.02017-05-12
03573026121631VIDAS® Quality Control307062019-11-19
B0744000160ASTUTE140 Electronic Quality Control (EQC) Device4000164000162016-08-12
B0745000090NEPHROCHECK Calibration Verification (Cal Vers) Kit5000095000092016-08-12
B0745000110NEPHROCHECK Test Kit 5000115000112016-08-12
B0745000130NEPHROCHECK Liquid Control Kit5000135000132016-08-12
03573026547226ETEST® Ertapenem (ETP)ETEST® Ertapenem (ETP)2016-11-18
03573026547271ETEST® Tobramycin (TM)ETEST® Tobramycin (TM)2016-11-18
03573026547295ETEST® Tigecycline (TGC)ETEST® Tigecycline (TGC)2016-11-18
03573026548674ETEST® Ampicillin/sulbactam (2/1) (AB)ETEST® Ampicillin/sulbactam (2/1) (AB)2016-11-18
03573026549046ETEST® Tetracycline (TC)ETEST® Tetracycline (TC)2016-11-18
03573026549077ETEST® Trimethoprim/sulfamethoxazole (1/19) (TS)ETEST® Trimethoprim/sulfamethoxazole (1/19) (TS)2016-11-18
03573026547196ETEST® Fosfomycin (FM)ETEST® Fosfomycin (FM)2016-11-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10382902154218BD BBL™ CHROMagar™ MRSA II / CHROMagar™ SABECTON, DICKINSON AND COMPANYJSO2024-08-22
30382902154212BD BBL™ CHROMagar™ MRSA II / CHROMagar™ SABECTON, DICKINSON AND COMPANYJSO2024-08-22
00816576026845HardyCHROM™HARDY DIAGNOSTICSJSO2023-12-08
00816576026838HardyCHROM™HARDY DIAGNOSTICSJSO2023-12-08
00848838085628SPECTRAREMEL, INC.JSO2022-12-22
00848838085635SPECTRAREMEL, INC.JSO2022-12-22
00816576026807HardyCHROMHARDY DIAGNOSTICSJSO2020-05-20
00816576025770HardyCHROM™HARDY DIAGNOSTICSJSO2019-10-21
03573026597719CHROMID® CARBA agarBIOMERIEUX SAJSO2018-09-28
03573026409913CHROMID® CARBA agarBIOMERIEUX SAJSO2018-09-28
03610521536208SelectBIO-RADJSO2018-02-09
03610521536215SelectBIO-RADJSO2018-02-09
00816576023097HardyCHROM™HARDY DIAGNOSTICSJSO2017-03-28
10382902152283BD BBL™ CHROMagar® MRSA IIBECTON, DICKINSON AND COMPANYJSO2016-12-23
30382902152287BD BBL™ CHROMagar® MRSA IIBECTON, DICKINSON AND COMPANYJSO2016-12-23
10382902152290BD BBL™ CHROMagar® MRSA IIBECTON, DICKINSON AND COMPANYJSO2016-12-21
10382902212406BD BBL™ GC II Agar with IsoVitaleX™ EnrichmentBECTON, DICKINSON AND COMPANYJSO2016-12-21
10382902219542BD BBL™ Haemophilus Test Medium Agar (HTM Agar)BECTON, DICKINSON AND COMPANYJSO2016-12-21
30382902212400BD BBL™ GC II Agar with IsoVitaleX™ EnrichmentBECTON, DICKINSON AND COMPANYJSO2016-12-21
30382902152294BD BBL™ CHROMagar® MRSA IIBECTON, DICKINSON AND COMPANYJSO2016-12-21
30382902219546BD BBL™ Haemophilus Test Medium Agar (HTM Agar)BECTON, DICKINSON AND COMPANYJSO2016-12-21
10382902153594BD BBL™ CHROMagar™ MRSA II / CHROMagar™ SABECTON, DICKINSON AND COMPANYJSO2016-12-16
30382902153598BD BBL™ CHROMagar™ MRSA II / CHROMagar™ SABECTON, DICKINSON AND COMPANYJSO2016-12-16
00848838004216NAREMEL, INC.JSO2016-12-09
05032384002924NAOXOID LIMITEDJSO2016-09-24
05032384003150NAOXOID LIMITEDJSO2016-09-24
05032384003174NAOXOID LIMITEDJSO2016-09-24
05032384003181NAOXOID LIMITEDJSO2016-09-24
05032384003198NAOXOID LIMITEDJSO2016-09-24
00848838000522NAREMEL, INC.JSO2016-09-24