FDA.reportPublic FDA data

SPECTRA

Primary DI
00848838085628
Brand
SPECTRA
Company
REMEL, INC.
Model
R01810
Catalog number
R01810
Device description
SPECTRA ESBL 10/Pk
Published
2022-12-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K162620000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162620000Remel Spectra ESBLRemel, Inc.2017-05-01JSO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00848838085628PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848838085628008488380856288488380856280848838085628

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.

Regulatory Flags#

DUNS number
065769564
Device count
1
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
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
00848838000546NAREMEL, INC.JSO2016-09-24