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CHROMID® VRE Agar

Primary DI
03573026552138
Brand
CHROMID® VRE Agar
Company
BIOMERIEUX SA
Model
chromID™ VRE Agar
Device description
Chromogenic medium for the qualitative detection of Enterococcus faecium and E. faecalis showing acquired vancomycin resistance (VRE) in stool specimens.
Published
2016-09-23
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
K091025000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K091025000CHROMID VRE AGAR, MODEL: REF 43 851bioMerieux, Inc.2010-03-02JSO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03573026313128PackageGS12In Commercial Distribution
03573026552138PrimaryGS10
03573026552145Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03573026313128035730263131283573026313128
03573026552138035730265521383573026552138
03573026552145035730265521453573026552145

GMDN Terms#

Term, Definition table
TermDefinition
Differential/selective agar culture medium IVDAn agar culture medium intended to be used to promote the selective growth of a microbial species with specific characteristics (e.g., antibiotic resistance, ability to utilize, synthesize specific metabolites) and/or distinguish between microbial species growing on the same medium by appearance (e.g., colour, shape, growth pattern). It typically contains substances to inhibit the growth of commensal or contaminating microorganisms (e.g., antimicrobials, dyes, salts) and/or dyes or chemical indicators for differentiation.

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
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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
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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
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30382902152287BD BBL™ CHROMagar® MRSA IIBECTON, DICKINSON AND COMPANYJSO2016-12-23
10382902152290BD BBL™ CHROMagar® MRSA IIBECTON, DICKINSON AND COMPANYJSO2016-12-21
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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