FDA.reportPublic FDA data

EDGE BIOLOGICALS INC

Primary DI
B6454P355
Brand
EDGE BIOLOGICALS INC
Company
EDGE BIOLOGICALS, INC.
Model
4P355
Device description
SCHAEDLER AGAR W/ 5% SHEEP BLOOD
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
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
B6454P355PrimaryHIBCC0
B6454P3551Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Enriched agar culture medium IVDAn agar culture medium supplemented with nutrient-rich substances (e.g., blood, serum) intended to enhance the growth and isolation of fastidious microorganisms from a clinical specimen and/or culture isolate. It is typically used to cultivate microorganisms that would not otherwise grow on general-purpose agar medium.

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
10818207025088Endocator Swabs (20pk)Vista DentalJSH2025-11-07
B6450715EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-21
B645T0711EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-21
B645T0713EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-21
B645T0714EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-21
B645T0718EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-21
B645T0722EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-21
B645T0771EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-21
B645T0772EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-21
B645T0775EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-21
B64507151EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-21
B645T07111EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-21
B645T07131EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-21
B645T07141EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-21
B645T07181EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-21
B645T07221EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-21
B645T07711EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-21
B645T07721EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-21
B645T07751EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-21
B6453B014EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-18
B6454P444EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-18
B645T0096EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-18
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
B645T00961EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-18
B6452P185EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-17
B6453P080EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-17
B645T0386EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSH2025-04-17