FDA.reportPublic FDA data

REMEL

Primary DI
00848838014031
Brand
REMEL
Company
REMEL, INC.
Model
R10141
Catalog number
R10141
Device description
Rice Grain medium (1ozBTL) 10/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
00848838014031PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848838014031008488380140318488380140310848838014031

GMDN Terms#

Term, Definition table
TermDefinition
Differential/selective agar culture medium IVDAn agar culture medium intended to be used to promote the selective growth of a microbial species with specific characteristics (e.g., antibiotic resistance, ability to utilize, synthesize specific metabolites) and/or distinguish between microbial species growing on the same medium by appearance (e.g., colour, shape, growth pattern). It typically contains substances to inhibit the growth of commensal or contaminating microorganisms (e.g., antimicrobials, dyes, salts) and/or dyes or chemical indicators for differentiation.

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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10818207025088Endocator Swabs (20pk)Vista DentalJSH2025-11-07
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B645T07721EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-21
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B6453B0141EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-18
B6454P3551EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-18
B6454P4441EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-18
B645B0318EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-18
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B6452P185EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-17
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