FDA.reportPublic FDA data

BACTICARD

Primary DI
00848838022432
Brand
BACTICARD
Company
REMEL, INC.
Model
R21106
Catalog number
R21106
Device description
BactiCard Candida 25TST/KT
Published
2022-12-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JXBKit, Identification, Yeast

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JXBKit, Identification, YeastMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00848838022432PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848838022432008488380224328488380224320848838022432

GMDN Terms#

Term, Definition table
TermDefinition
Bacterial species differentiation disc IVDOne or multiple diagnostic discs impregnated with an antibacterial/antibiotic agent (i.e., a drug intended for treatment and/or prevention of a bacterial infection) or microbial test reagent, intended to be used for the presumptive identification of a bacterial specie(s) [excluding mycobateria] isolated from a clinical specimen by culture, based on specific characteristics (e.g., antibiotic resistance, ability to utilize and/or synthesize specific metabolites).

Regulatory Flags#

DUNS number
065769564
Device count
1
Premarket exempt
true
Kit
true
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
00848838058455Remel™ RapID™ ERIC™ (ELECTRONIC RAPID IDENTIFICATION COMPENDIUM)REMEL, INC.JXB2024-11-13
15099590658106MicroScanBeckman Coulter, Inc.JXB2022-12-05
15099590655716MicroScanBeckman Coulter, Inc.JXB2022-11-15
15099590655792MicroScanBeckman Coulter, Inc.JXB2022-11-15
15099590655839MicroScanBeckman Coulter, Inc.JXB2022-11-15
00848838058233Remel REMEL, INC.JXB2021-11-12
30848838058234Remel REMEL, INC.JXB2021-11-12
03848838058230Remel REMEL, INC.JXB2021-11-12
03573026529697VITEK® 2 YSTBIOMERIEUX , INC.JXB2020-06-02
03573026131937VITEK® 2 YSTBIOMERIEUX , INC.JXB2020-06-02
03573026048082API® 20 C AUXBIOMERIEUX SAJXB2020-04-10
03573026066383ID 32 CBIOMERIEUX SAJXB2020-04-10
00382904483166BD Phoenix™ YEAST IDBECTON, DICKINSON AND COMPANYJXB2018-05-25
30382904483167BD Phoenix™ Yeast IDBECTON, DICKINSON AND COMPANYJXB2018-05-25