FDA.reportPublic FDA data

REMEL

Primary DI
00848838008658
Brand
REMEL
Company
REMEL, INC.
Model
R062032
Catalog number
R062032
Device description
ONPG Broth (1ml) 20/PK
Published
2022-12-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00848838008658PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848838008658008488380086588488380086580848838008658

GMDN Terms#

Term, Definition table
TermDefinition
Culture medium controlA device that consists of paper discs, or other suitable material, each impregnated with a specific freeze-dried, viable microorganism used to determine if a given culture medium is able to support the growth of that microorganism.

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
00810144911007RediporAnalytiChem USA, Inc.JSF2023-12-08
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
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