FDA.reportPublic FDA data

Redipor

Primary DI
00810144911267
Brand
Redipor
Company
AnalytiChem USA, Inc.
Model
1
Catalog number
X1100
Device description
Voges-Proskauer 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
00810144911267PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810144911267008101449112678101449112670810144911267

GMDN Terms#

Term, Definition table
TermDefinition
Voges-Proskauer (VP) microbial reagent IVDOne or multiple substances or reactants, referred to as VP (Voges-Proskauer) reagent, intended to be used in microbial testing to determine the ability of a microorganism, isolated from a clinical specimen by culture, to convert pyruvate to acetoin.

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
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
00848838022845REMELREMEL, INC.JTO2023-01-03