FDA.reportPublic FDA data

NA

Primary DI
00848838076824
Brand
NA
Company
REMEL, INC.
Model
R01830
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
K092819000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092819000REMEL SPECTRA VREThermo Fisher Scientific2010-07-15JSO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00848838076824PrimaryGS10
00848838099526Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848838076824008488380768248488380768240848838076824
00848838099526008488380995268488380995260848838099526

GMDN Terms#

Term, Definition table
TermDefinition
Chromogenic VRE agar culture medium IVDA selective and/or differential agar culture medium containing specified chromogenic substrates intended to be used to screen for the presence of Vancomycin-resistant Enterococci (VRE) in a clinical specimen.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8002556730ITechnicalSupport@remel.com

Regulatory Flags#

DUNS number
065769564
Device count
10
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00848838018855NACP114-102016-09-24
00848838031274REMELR40041R400412023-01-03
00842558116709Spectra™ Candida Agar R018332026-02-09
00848838072772MicroTest M6R12582R125822022-12-22
00848838074844MicroTest M4RTR12567R125672022-12-22
00848838075018MicroTest M6R12560R125602022-12-22
00848838091827NA7115-602022-04-21
00848838091742VersaTREK™ VersaTREK™ Myco Streptomycin, 7120-302025-01-16
00848838091834NA7116-702016-12-09
00848838003158Strep Selective II AgarR018592026-01-16
00848838059865^BM^ PK/50 OXIDASE TESTR90556352026-01-16
00848838066856Liquid Amies,Dual Swab PK/50R7230952025-06-18
00848838066887Liquid Stuarts,Single Swab PK/500R7231102025-06-18
00848838066894Liquid Stuarts,Single Swab PK/50R7231152025-06-18
00848838066900Liquid Stuarts,Dual Swab PK/500R7231202025-06-18
00848838066917Liquid Stuarts,Dual Swab PK/50R7231252025-06-18
00848838066924Liquid Stuarts,Wire Shaft Swab PK/100R7231302025-06-18
00848838066931Liquid Stuarts,Wire Shaft PK/50R7231352025-06-18
00848838011177Sensititre Demineralized WaterT33392023-12-21
00842558105611^CE^Liq Stuarts,Dual Swab 36mmPK/500r97231202025-10-02

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