FDA.reportPublic FDA data

Remel

Primary DI
00848838028779
Brand
Remel
Company
REMEL, INC.
Model
R30851401
Device description
Candida albicans screen 50TST/KT
Published
2022-04-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JXCKit, Screening, Yeast

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JXCKit, Screening, YeastMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00848838028779PrimaryGS10
30848838028770Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848838028779008488380287798488380287790848838028779
3084883802877030848838028770

GMDN Terms#

Term, Definition table
TermDefinition
Multiple Candida/yeast 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 Candida and/or yeast isolated by culture from a clinical specimen.

Contacts#

Phone, Email table
PhoneEmail
8002556730csemal@thermofisher.com

Regulatory Flags#

DUNS number
065769564
Device count
50
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
00810047420361N/AScientific Device Laboratory, Inc.JXC2023-01-30
00848838010163REMELREMEL, INC.JXC2023-01-04
00848838022289REMELREMEL, INC.JXC2023-01-04
00848838022296REMELREMEL, INC.JXC2023-01-04
30848838028770Remel REMEL, INC.JXC2022-04-21