FDA.reportPublic FDA data

Redipor

Primary DI
00810144911038
Brand
Redipor
Company
AnalytiChem USA, Inc.
Model
1
Catalog number
T1630
Device description
OF Medium w/ Dextrose
Published
2023-09-21
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
00810144911038PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810144911038008101449110388101449110380810144911038

GMDN Terms#

Term, Definition table
TermDefinition
Differential/selective agar culture medium IVDAn agar culture medium intended to be used to promote the selective growth of a microbial species with specific characteristics (e.g., antibiotic resistance, ability to utilize, synthesize specific metabolites) and/or distinguish between microbial species growing on the same medium by appearance (e.g., colour, shape, growth pattern). It typically contains substances to inhibit the growth of commensal or contaminating microorganisms (e.g., antimicrobials, dyes, salts) and/or dyes or chemical indicators for differentiation.

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
00810144911007RediporAnalytiChem USA, Inc.JSF2023-12-08
00810144910994RediporAnalytiChem USA, Inc.JSF2023-09-21
00810144911014RediporAnalytiChem USA, Inc.JSF2023-09-21
00810144911021RediporAnalytiChem 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