FDA.reportPublic FDA data

Redipor

Primary DI
00810144911007
Brand
Redipor
Company
AnalytiChem USA, Inc.
Model
1
Catalog number
T1475
Device description
Indole Broth
Published
2023-12-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
JSFCulture Media, Single Biochemical Test

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JSFCulture Media, Single Biochemical TestMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810144911007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810144911007008101449110078101449110070810144911007

GMDN Terms#

Term, Definition table
TermDefinition
Indole broth/peptone water microbial reagent IVDA substance or reactant, sometimes referred to as indole broth or peptone water, intended to be used in the testing of a microorganism isolated from a clinical specimen by culture, to detect the presence of enzymes that split indole from the amino acid tryptophan.

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
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
00810144910079Redipor1P50502023-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810144910994RediporAnalytiChem USA, Inc.JSF2023-09-21
00810144911014RediporAnalytiChem USA, Inc.JSF2023-09-21
00810144911021RediporAnalytiChem USA, Inc.JSF2023-09-21
00810144911038RediporAnalytiChem USA, Inc.JSF2023-09-21
00810144911045RediporAnalytiChem USA, Inc.JSF2023-09-21
00810144911052RediporAnalytiChem USA, Inc.JSF2023-09-21
00810144911069RediporAnalytiChem USA, Inc.JSF2023-09-21
00848838002625REMELREMEL, INC.JSF2022-12-27
00848838008405REMELREMEL, INC.JSF2022-12-27
00848838008412REMELREMEL, INC.JSF2022-12-27
00848838008429REMELREMEL, INC.JSF2022-12-27
00848838008474REMELREMEL, INC.JSF2022-12-27
00848838008498REMELREMEL, INC.JSF2022-12-27
00848838008504REMELREMEL, INC.JSF2022-12-27
00848838008511REMELREMEL, INC.JSF2022-12-27
00848838008573REMELREMEL, INC.JSF2022-12-27
00848838008597REMELREMEL, INC.JSF2022-12-27
00848838008658REMELREMEL, INC.JSF2022-12-27
00848838008719REMELREMEL, INC.JSF2022-12-27
00848838008757REMELREMEL, INC.JSF2022-12-27
00848838008771REMELREMEL, INC.JSF2022-12-27
00848838008801REMELREMEL, INC.JSF2022-12-27
00848838008856REMELREMEL, INC.JSF2022-12-27
00848838008863REMELREMEL, INC.JSF2022-12-27
00848838008870REMELREMEL, INC.JSF2022-12-27
00848838008894REMELREMEL, INC.JSF2022-12-27
00848838008917REMELREMEL, INC.JSF2022-12-27
00848838008955REMELREMEL, INC.JSF2022-12-27
00848838008962REMELREMEL, INC.JSF2022-12-27
00848838008986REMELREMEL, INC.JSF2022-12-27