FDA.reportPublic FDA data

Remel

Primary DI
00848838058271
Brand
Remel
Company
REMEL, INC.
Model
R8311008
Device description
RapID CB PLUS System 20/KT
Published
2021-11-13
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
JTODiscs, Strips And Reagents, Microorganism Differentiation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JTODiscs, Strips And Reagents, Microorganism DifferentiationMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00848838058271PrimaryGS10
30848838058272Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848838058271008488380582718488380582710848838058271
3084883805827230848838058272

GMDN Terms#

Term, Definition table
TermDefinition
Multiple aerobic gram positive bacteria species culture isolate identification IVD, kitA collection of reagents and other associated materials intended to be used for the differentiation and/or identification of one or multiple species of aerobic gram positive bacteria that have been isolated by culture from a clinical specimen. Bacteria which may be identified typically belong to the genera Staphylococcus, Enterococcus, or may represent other gram positive cocci and gram positive bacilli genera.

Contacts#

Phone, Email table
PhoneEmail
8002556730csemal@thermofisher.com

Regulatory Flags#

DUNS number
065769564
Device count
20
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
00848838059865^BM^ PK/50 OXIDASE TESTREMEL, INC.JTO2026-01-16
05032384007080BLANK DISCSOXOID LIMITEDJTO2024-07-11
05032384188796Oxoid™ Bacitracin Diagnostic DiscsOXOID LIMITEDJTO2024-07-08
00816576025121N/AHARDY DIAGNOSTICSJTO2024-01-08
00819398021586N/AHARDY DIAGNOSTICSJTO2024-01-08
00810144911229RediporAnalytiChem USA, Inc.JTO2023-09-21
00810144911236RediporAnalytiChem USA, Inc.JTO2023-09-21
00810144911243RediporAnalytiChem USA, Inc.JTO2023-09-21
00810144911250RediporAnalytiChem USA, Inc.JTO2023-09-21
00810144911267RediporAnalytiChem USA, Inc.JTO2023-09-21
00810144911274RediporAnalytiChem USA, Inc.JTO2023-09-21
00810144911281RediporAnalytiChem USA, Inc.JTO2023-09-21
00816576029136HardyDisk™HARDY DIAGNOSTICSJTO2023-04-26
00816576029129HardyDisk™HARDY DIAGNOSTICSJTO2023-04-26
00848838002106REMELREMEL, INC.JTO2023-01-03
00848838004131REMELREMEL, INC.JTO2023-01-03
00848838008672REMELREMEL, INC.JTO2023-01-03
00848838022357REMELREMEL, INC.JTO2023-01-03
00848838022395REMELREMEL, INC.JTO2023-01-03
00848838022517REMELREMEL, INC.JTO2023-01-03
00848838022531REMELREMEL, INC.JTO2023-01-03
00848838022579REMELREMEL, INC.JTO2023-01-03
00848838022593REMELREMEL, INC.JTO2023-01-03
00848838022616REMELREMEL, INC.JTO2023-01-03
00848838022630REMELREMEL, INC.JTO2023-01-03
00848838022678REMELREMEL, INC.JTO2023-01-03
00848838022715REMELREMEL, INC.JTO2023-01-03
00848838022746REMELREMEL, INC.JTO2023-01-03
00848838022784REMELREMEL, INC.JTO2023-01-03
00848838022821REMELREMEL, INC.JTO2023-01-03