FDA.reportPublic FDA data

EDGE BIOLOGICALS INC

Primary DI
B645T0061
Brand
EDGE BIOLOGICALS INC
Company
EDGE BIOLOGICALS, INC.
Model
T0061
Device description
BHI BROTH 10ML
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
JSCCulture Media, General Nutrient Broth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JSCCulture Media, General Nutrient BrothMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B645T0061PrimaryHIBCC0
B645T00611Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Basic/simple nutrient broth culture medium IVDA non-selective, non-differential nutrient broth culture medium intended to be used to for the primary growth and isolation of typically non-fastidious microorganisms from a clinical specimen.

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

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Primary DI, Brand, Company table
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B645T0040EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSC2025-04-18
B645T0041EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSC2025-04-18
B645T0046EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSC2025-04-18
B645T0047EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSC2025-04-18
B645T0051EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSC2025-04-18