FDA.reportPublic FDA data

REMEL

Primary DI
00848838010972
Brand
REMEL
Company
REMEL, INC.
Model
R07097
Catalog number
R07097
Device description
Diamonds Medium, Modified (10ml) 20/PK
Published
2023-01-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00848838010972PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848838010972008488380109728488380109720848838010972

GMDN Terms#

Term, Definition table
TermDefinition
Enriched broth culture medium IVDA broth 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 in a general-purpose broth medium.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
065769564
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
00848838018855NACP114-102016-09-24
00848838031274REMELR40041R400412023-01-03
00842558116709Spectra™ Candida Agar R018332026-02-09
00848838072772MicroTest M6R12582R125822022-12-22
00848838074844MicroTest M4RTR12567R125672022-12-22
00848838075018MicroTest M6R12560R125602022-12-22
00848838091827NA7115-602022-04-21
00848838091742VersaTREK™ VersaTREK™ Myco Streptomycin, 7120-302025-01-16
00848838091834NA7116-702016-12-09
00848838003158Strep Selective II AgarR018592026-01-16
00848838059865^BM^ PK/50 OXIDASE TESTR90556352026-01-16
00848838066856Liquid Amies,Dual Swab PK/50R7230952025-06-18
00848838066887Liquid Stuarts,Single Swab PK/500R7231102025-06-18
00848838066894Liquid Stuarts,Single Swab PK/50R7231152025-06-18
00848838066900Liquid Stuarts,Dual Swab PK/500R7231202025-06-18
00848838066917Liquid Stuarts,Dual Swab PK/50R7231252025-06-18
00848838066924Liquid Stuarts,Wire Shaft Swab PK/100R7231302025-06-18
00848838066931Liquid Stuarts,Wire Shaft PK/50R7231352025-06-18
00848838011177Sensititre Demineralized WaterT33392023-12-21
00842558105611^CE^Liq Stuarts,Dual Swab 36mmPK/500r97231202025-10-02

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
00810144911144RediporAnalytiChem 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
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