FDA.reportPublic FDA data

EDGE BIOLOGICALS INC

Primary DI
B645T0800
Brand
EDGE BIOLOGICALS INC
Company
EDGE BIOLOGICALS, INC.
Model
T0800
Device description
LIM BROTH 5ML
Published
2025-04-18
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
JSJCulture Media, Selective And Non-Differential

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B645T0800PrimaryHIBCC0
B645T08001Unit of UseHIBCC0

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.

Regulatory Flags#

DUNS number
047927827
Device count
10
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B645GS101EDGE BIOLOGICALS INCGS1012025-04-22
B645GS102EDGE BIOLOGICALS INCGS1022025-04-22
B645GS103EDGE BIOLOGICALS INCGS1032025-04-22
B6450715EDGE BIOLOGICALS INCT07152025-04-21
B6453P395EDGE BIOLOGICALS INC3P3952025-04-21
B645T0415EDGE BIOLOGICALS INCT04152025-04-21
B645T0453EDGE BIOLOGICALS INCT04532025-04-21
B645T0466EDGE BIOLOGICALS INCT04662025-04-21
B645T0481EDGE BIOLOGICALS INCT04812025-04-21
B645T0486EDGE BIOLOGICALS INCT04862025-04-21
B645T0488EDGE BIOLOGICALS INCT04882025-04-21
B645T0496EDGE BIOLOGICALS INCT04962025-04-21
B645T0577EDGE BIOLOGICALS INCT05772025-04-21
B645T0615EDGE BIOLOGICALS INCT06152025-04-21
B645T0641EDGE BIOLOGICALS INCT06412025-04-21
B645T0711EDGE BIOLOGICALS INCT07112025-04-21
B645T0713EDGE BIOLOGICALS INCT07132025-04-21
B645T0714EDGE BIOLOGICALS INCT07142025-04-21
B645T0718EDGE BIOLOGICALS INCT07182025-04-21
B645T0722EDGE BIOLOGICALS INCT07222025-04-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10382902149832BD BBL™ CHROMagar™ SalmonellaBECTON, DICKINSON AND COMPANYJSJ2026-04-03
10382902218729BD BBL™ TCBS AgarBECTON, DICKINSON AND COMPANYJSJ2026-04-03
B6453P395EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSJ2025-04-21
B6451R009EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSJ2025-04-18
B6453P275EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSJ2025-04-18
B6453P390EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSJ2025-04-18
B6454P256EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSJ2025-04-18
B6454P330EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSJ2025-04-18
B6454P230EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSJ2025-04-17
B645T0004EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSJ2025-04-17
B645T0631EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSJ2025-04-17
10382902978791BD BBL™ BCYE Selective Agar w/PACBECTON, DICKINSON AND COMPANYJSJ2024-09-17
10382902981913BD BBL™ Inhibitory Mold Agar Deep FillBECTON, DICKINSON AND COMPANYJSJ2024-08-29
10382902216015BD BBL™ Columbia CNA Agar with 5% SB and BD BBL MacConkey II Agar BD I Plate™BECTON, DICKINSON AND COMPANYJSJ2024-08-23
00848838001048REMELREMEL, INC.JSJ2023-01-03
00848838001055REMELREMEL, INC.JSJ2023-01-03
00848838001086REMELREMEL, INC.JSJ2023-01-03
00848838001093REMELREMEL, INC.JSJ2023-01-03
00848838001116REMELREMEL, INC.JSJ2023-01-03
00848838001437REMELREMEL, INC.JSJ2023-01-03
00848838001451REMELREMEL, INC.JSJ2023-01-03
00848838000119REMELREMEL, INC.JSJ2022-12-30
00848838000201REMELREMEL, INC.JSJ2022-12-30
00848838000348REMELREMEL, INC.JSJ2022-12-30
00848838000355REMELREMEL, INC.JSJ2022-12-30
00848838000423REMELREMEL, INC.JSJ2022-12-30
00848838000430REMELREMEL, INC.JSJ2022-12-30
00848838000447REMELREMEL, INC.JSJ2022-12-30
00848838000461REMELREMEL, INC.JSJ2022-12-30
00848838000478REMELREMEL, INC.JSJ2022-12-30