FDA.reportPublic FDA data

REMEL

Primary DI
00848838009754
Brand
REMEL
Company
REMEL, INC.
Model
R064502
Catalog number
R064502
Device description
Selenite Broth (9ml) 20/PK
Published
2022-12-23
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
JSDCulture Media, Selective Broth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JSDCulture Media, Selective BrothMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00848838009754PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848838009754008488380097548488380097540848838009754

GMDN Terms#

Term, Definition table
TermDefinition
Differential/selective broth culture medium IVDA broth 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 in the same medium. 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
38053326011772LBM CABrothCOPAN ITALIA SPAJSD2025-09-22
08053326011771LBM CABrothCOPAN ITALIA SPAJSD2025-09-22
05407010128642TSB 3%:10 L bag (empty bag capacity)Lonza VerviersJSD2025-09-15
05407010128666TSB 3%:1000 L bag (empty bag capacity)Lonza VerviersJSD2025-09-15
05407010128673TSB 3%:500 L bag (empty bag capacity)Lonza VerviersJSD2025-09-15
05407010128680TSB 3%:1 L bag SAMPLELonza VerviersJSD2025-09-15
05407010128697TSB 3%:50 L bag (empty bag capacity)Lonza VerviersJSD2025-09-15
05032384003914SELENITE CYST.BROTH BASEOXOID LIMITEDJSD2025-07-23
05407010127164Tryptic Soy Broth 15g/L 100mlLonza VerviersJSD2025-05-26
05407010127171Tryptic Soy Broth 15g/L 500mlLonza VerviersJSD2025-05-26
05407010127188Tryptic Soy Broth 15g/L, 500ML bagLonza VerviersJSD2025-05-26
05407010127195Tryptic Soy Broth 15g/L 2L in 20L bagLonza VerviersJSD2025-05-26
05407010127201Tryptic Soy Broth 15g/L - 5ml tubeLonza VerviersJSD2025-05-26
054070101272183% w/v TSB, 500 ml bag Sample close systLonza VerviersJSD2025-05-26
054070101272253% w/v TSB, 500 ml bag Sample open systLonza VerviersJSD2025-05-26
054070101272323% w/v TSB - 1 L bagLonza VerviersJSD2025-05-26
054070101272493% w/v TSB - 200 L bagLonza VerviersJSD2025-05-26
054070101272563% w/v TSB - 50 L bagLonza VerviersJSD2025-05-26
05407010127263Tryptic Soy Broth 1L bag - SAMPLELonza VerviersJSD2025-05-26
05407010127270Tryptic Soy Broth 200L bagLonza VerviersJSD2025-05-26
054070101272873% W/V TSB - 1L bag SampleLonza VerviersJSD2025-05-26
054070101272943% W/V TSB - 10L bagLonza VerviersJSD2025-05-26
05407010127300TSB 3% : 1L bag SAMPLELonza VerviersJSD2025-05-26
B645T0641EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSD2025-04-21
B645T0736EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSD2025-04-21
B645T0763EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSD2025-04-21
B645T0781EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSD2025-04-21
B645T2255EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSD2025-04-21
B645T06411EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSD2025-04-21
B645T07361EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSD2025-04-21