FDA.reportPublic FDA data

Redipor

Primary DI
00810144911144
Brand
Redipor
Company
AnalytiChem USA, Inc.
Model
1
Catalog number
T1350
Device description
Cooked Meat w/ Dextrose, Hemin & Vitamin K
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
KZICulture Media, Enriched

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KZICulture Media, EnrichedMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810144911144PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810144911144008101449111448101449111440810144911144

GMDN Terms#

Term, Definition table
TermDefinition
Enriched agar culture medium IVDAn agar culture medium supplemented with nutrient-rich substances (e.g., blood, serum) intended to enhance the growth and isolation of fastidious microorganisms from a clinical specimen and/or culture isolate. It is typically used to cultivate microorganisms that would not otherwise grow on general-purpose agar medium.

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
10382902218088BD BBL™ BCYE AgarBECTON, DICKINSON AND COMPANYKZI2024-09-19
30382902218082BD BBL™ BCYE AgarBECTON, DICKINSON AND COMPANYKZI2024-09-19
00850056467063Schaedler Blood Agar OxyPlateOxyrase, Inc.KZI2023-11-30
00810144911120RediporAnalytiChem USA, Inc.KZI2023-09-21
00810144911151RediporAnalytiChem USA, Inc.KZI2023-09-21
05051716000155AIM-V MediumOxford Immunotec, Inc.KZI2023-02-07
05051716000162AIM-V MediumOxford Immunotec, Inc.KZI2023-02-07
00848838001505REMELREMEL, INC.KZI2023-01-04
00848838010965REMELREMEL, INC.KZI2023-01-04
00848838010972REMELREMEL, INC.KZI2023-01-04
00848838012136REMELREMEL, INC.KZI2023-01-04
00848838012174REMELREMEL, INC.KZI2023-01-04
00819398020565N/AHARDY DIAGNOSTICSKZI2022-07-25
00819398020558N/AHARDY DIAGNOSTICSKZI2022-07-25
00819398028431N/AHARDY DIAGNOSTICSKZI2020-09-02
00816576027576N/AHARDY DIAGNOSTICSKZI2020-06-08
00816576027613N/AHARDY DIAGNOSTICSKZI2020-06-08
00819398024228HardyFlask™HARDY DIAGNOSTICSKZI2020-06-08
00819398024242HardyFlask™HARDY DIAGNOSTICSKZI2020-06-08
00819398024266HardyFlask™HARDY DIAGNOSTICSKZI2020-06-08
00819398024235HardyFlask™HARDY DIAGNOSTICSKZI2020-06-08
00816576027262N/AHARDY DIAGNOSTICSKZI2020-06-05
00816576027477N/AHARDY DIAGNOSTICSKZI2020-06-05
00819398023535N/AHARDY DIAGNOSTICSKZI2020-06-05
00819398023528N/AHARDY DIAGNOSTICSKZI2020-06-05
00819398022194N/AHARDY DIAGNOSTICSKZI2020-06-03
00819398022293N/AHARDY DIAGNOSTICSKZI2020-06-03
00819398028127N/AHARDY DIAGNOSTICSKZI2020-06-03
00819398022187N/AHARDY DIAGNOSTICSKZI2020-06-03
00819398022286N/AHARDY DIAGNOSTICSKZI2020-06-03