FDA.report

EDGE BIOLOGICALS INC

Primary DI
B6454P3751
Brand
EDGE BIOLOGICALS INC
Company
EDGE BIOLOGICALS, INC.
Model
4P375
Device description
MACCONKEY AGAR W/ 1% MALTOSE
Published
2025-04-17
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
JSICulture Media, Selective And Differential

Product Code Classifications

CodeDeviceSpecialtyClass
JSICulture Media, Selective And DifferentialMicrobiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B6454P375PrimaryHIBCC0
B6454P3751Unit of UseHIBCC0

GMDN Terms

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

Regulatory Flags

DUNS number
047927827
Device count
10
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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