FDA.reportPublic FDA data

REMEL

Primary DI
00848838031922
Brand
REMEL
Company
REMEL, INC.
Model
R450600
Catalog number
R450600
Device description
OADC Enrichment (2ml) PK/10
Published
2023-01-03
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JSKSupplement, Culture Media

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JSKSupplement, Culture MediaMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00848838031922PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848838031922008488380319228488380319220848838031922

GMDN Terms#

Term, Definition table
TermDefinition
Culture medium antimicrobial supplement IVDA culture medium supplement containing one or multiple antimicrobials that is intended to be used to suppress or inhibit the growth of native or resident microorganisms present in a clinical specimen to enhance recovery, isolation, and/or growth of pathogenic organisms.

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
05407010128727ProLipid Complex - 50 ml SAMPLELonza VerviersJSK2025-09-15
05407010128734ProLipid Complex - 1010 mlLonza VerviersJSK2025-09-15
05407010128741Rec. Hum. Insulin ( # 4506) Suppl - 10LLonza VerviersJSK2025-09-15
05407010128758Rec. Hum. Insulin ( # 4506) Suppl - 500LLonza VerviersJSK2025-09-15
05407010128765Mod ProCHO 5 powder Sup 2 - 20 mlLonza VerviersJSK2025-09-15
05407010128772Mod ProCHO 5 powder Sup 2 - 500LLonza VerviersJSK2025-09-15
05407010128284Ferric Citrate solution - 400 mlLonza VerviersJSK2025-08-11
05407010128246Insulin Solution - 50 ml SAMPLELonza VerviersJSK2025-08-08
05407010128253Insulin Solution - 900 mlLonza VerviersJSK2025-08-08
05407010128260Ferric Citrate solution - 50 ml SAMPLELonza VerviersJSK2025-08-08
05407010128277Ferric Citrate solution - 1L bottleLonza VerviersJSK2025-08-08
05407010127126DMEM Vitamines Stock 100x 1LLonza VerviersJSK2025-05-26
05407010127010MCDB 202 Trace Element BulkLonza VerviersJSK2025-05-23
05407010127034CHO4A Trace element stock - 1L bottleLonza VerviersJSK2025-05-23
05407010127041Stock solution CH-0107N (0.7g/L)Lonza VerviersJSK2025-05-23
05407010127058Stock solution SP-0180T (0.095 g/l)Lonza VerviersJSK2025-05-23
05407010127065Stock solution CH-0146T (0.078 g/l)Lonza VerviersJSK2025-05-23
05407010127072Stock solution CH-0242 (0.4711 g/l)Lonza VerviersJSK2025-05-23
05407010127089Stock solution CH-0116N (0.2162 g/l)Lonza VerviersJSK2025-05-23
05407010127096Stock solution CH-0149N (35.67 mg/l)Lonza VerviersJSK2025-05-23
05407010127102Stock solution CH-0149N (35.67 mg/l)Lonza VerviersJSK2025-05-23
05407010127119CHO7 Lipids 2x 500 ml (resa CSL Behring)Lonza VerviersJSK2025-05-23
05407010126976Lipid Mix CM-105 NN It.no.101-5986-500mlLonza VerviersJSK2025-05-20
05407010126983Lipid Mix CM-105 NN It.no.101-5986 - 20LLonza VerviersJSK2025-05-20
05407010126648SF5-16 Powder Medium - Sup 1 for 5LLonza VerviersJSK2025-04-17
05407010126655SF5-16 Powder Medium - Sup 1 for 500LLonza VerviersJSK2025-04-17
05407010126662SF5-16 Powder Medium - Sup 2 - 5LLonza VerviersJSK2025-04-17
05407010126679SF5-16 Powder Medium - Sup 2 - 500LLonza VerviersJSK2025-04-17
05407010126426proVero complement powder - 500LLonza VerviersJSK2025-03-31
05407010126327GSK-IC-01 supplem. powder 200LLonza VerviersJSK2025-03-25