FDA.reportPublic FDA data

REMEL

Primary DI
00848838000195
Brand
REMEL
Company
REMEL, INC.
Model
R01061
Catalog number
R01061
Device description
Anaer Reducible Blood Agar 15/PK
Published
2022-12-22
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
JSHCulture Media, Non-Selective And Differential

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JSHCulture Media, Non-Selective And DifferentialMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00848838000195PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848838000195008488380001958488380001950848838000195

GMDN Terms#

Term, Definition table
TermDefinition
Anaerobic-microorganism antimicrobial susceptibility culture medium IVDA non-selective culture medium intended to be used to perform diagnostic antimicrobial susceptibility testing of anaerobic microorganisms isolated from a clinical specimen.

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
00848838065361ImmunoDOT Autoimmunity Panel 1 KT/100TSTR24709402026-07-20
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10818207025088Endocator Swabs (20pk)Vista DentalJSH2025-11-07
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B6453B014EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-18
B6454P355EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-18
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B6453B0141EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-18
B6454P3551EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-18
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