FDA.reportPublic FDA data

Redipor

Primary DI
00810144911274
Brand
Redipor
Company
AnalytiChem USA, Inc.
Model
1
Catalog number
X1250
Device description
Nitrate Reagent A
Published
2023-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00810144911274PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810144911274008101449112748101449112740810144911274

GMDN Terms#

Term, Definition table
TermDefinition
Nitrate reduction microbial reagent IVDOne or multiple substances or reactants intended to be used in microbial testing to detect nitratase enzyme production, by demonstrating the reduction of nitrate through a visible colour change in an organism isolated from a clinical specimen by culture.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
071749709
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810144911526Redipor1CHRP00382026-01-27
00810144911472Redipor12025-11-26
00810144911496Cell Pro1FTMT002025-11-26
00810144911502Cell Pro1BHIBT002025-11-26
00810144911519Cell Pro1T20052025-11-26
00810144911359Redipor1CHRP00262025-01-12
00810144911366Redipor1T20042024-05-15
00810144911007Redipor1T14752023-12-08
00810144911311Redipor1T30172023-12-08
00810144911328Redipor1T30192023-12-08
00810144911335Redipor1CHRP00162023-12-08
00810144911342Redipor1T14582023-12-08
00810144911304Redipor1T16542023-09-28
00810144910000Redipor12023-09-21
00810144910017Redipor1P15102023-09-21
00810144910024Redipor1P15512023-09-21
00810144910031Redipor1P11202023-09-21
00810144910048Redipor1P16402023-09-21
00810144910055Redipor1P10702023-09-21
00810144910062Redipor1P12502023-09-21

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
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
00848838022845REMELREMEL, INC.JTO2023-01-03