FDA.reportPublic FDA data

Remel

Primary DI
00848838058110
Brand
Remel
Company
REMEL, INC.
Model
R8311004
Device description
RapID SS/u System KT/20
Published
2021-11-12
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
JSSKit, Identification, Enterobacteriaceae

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JSSKit, Identification, EnterobacteriaceaeMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00848838058110PrimaryGS10
30848838058111Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848838058110008488380581108488380581100848838058110
3084883805811130848838058111

GMDN Terms#

Term, Definition table
TermDefinition
Multiple urinary tract pathogen culture isolate identification IVD, kit, rapidA collection of reagents and other associated materials intended to be used for the differentiation and/or identification of one or multiple pathogens associated with urinary tract infection, isolated by culture from a clinical specimen, and requiring less incubation time than standard laboratory methods. Organisms may include (but are not limited to) Escherichia coli, Proteus mirabilis, Klebsiella, Staphylococcus aureus, and Candida albicans.

Contacts#

Phone, Email table
PhoneEmail
8002556730csemail@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
00848838023040REMELREMEL, INC.JSS2023-01-03
00848838058196RemelREMEL, INC.JSS2021-11-12
30848838058111Remel REMEL, INC.JSS2021-11-12
30848838058197RemelREMEL, INC.JSS2021-11-12
03848838058117Remel REMEL, INC.JSS2021-11-12
03848838058193RemelREMEL, INC.JSS2021-11-12
03573026588410API® 20 E Reagent QCBIOMERIEUX SAJSS2020-04-10
03573026588489API® 20 EBIOMERIEUX SAJSS2020-04-10
03573026588526RAPID 20 E™BIOMERIEUX SAJSS2020-04-10
03573026588649RAPID ID 32 EBIOMERIEUX SAJSS2020-04-10
03573026047702API® 20 NEBIOMERIEUX SAJSS2020-04-10
03573026048136API® 20 E Reagent QCBIOMERIEUX SAJSS2020-04-10
03573026048013API 20 E™BIOMERIEUX SAJSS2020-04-10
03573026048617RAPID 20 E™BIOMERIEUX SAJSS2020-04-10
03573026066574rapid ID 32 EBIOMERIEUX SAJSS2020-04-10
03573026092443ID indole TDABIOMERIEUX SAJSS2019-07-19