FDA.report

EDGE BIOLOGICALS INC

Primary DI
B6454P2301
Brand
EDGE BIOLOGICALS INC
Company
EDGE BIOLOGICALS, INC.
Model
4P230
Device description
MIDDLEBROOK 7H10 AGAR
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
JSJCulture Media, Selective And Non-Differential

Product Code Classifications

CodeDeviceSpecialtyClass
JSJCulture Media, Selective And Non-DifferentialMicrobiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B6454P230PrimaryHIBCC0
B6454P2301Unit of UseHIBCC0

GMDN Terms

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.

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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
B645GS101EDGE BIOLOGICALS INCGS1012025-04-22
B645GS102EDGE BIOLOGICALS INCGS1022025-04-22
B645GS103EDGE BIOLOGICALS INCGS1032025-04-22
B64507151EDGE BIOLOGICALS INCT07152025-04-21
B6453P3951EDGE BIOLOGICALS INC3P3952025-04-21
B645GB123EDGE BIOLOGICALS INCGB1232025-04-21
B645MR115EDGE BIOLOGICALS INCMR1152025-04-21
B645SB100DEF1EDGE BIOLOGICALS INCSB100DEF2025-04-21
B645SB50DEF1EDGE BIOLOGICALS INCSB50DEF2025-04-21
B645T04151EDGE BIOLOGICALS INCT04152025-04-21
B645T04531EDGE BIOLOGICALS INCT04532025-04-21
B645T04661EDGE BIOLOGICALS INCT04662025-04-21
B645T04811EDGE BIOLOGICALS INCT04812025-04-21
B645T04861EDGE BIOLOGICALS INCT04862025-04-21
B645T04881EDGE BIOLOGICALS INCT04882025-04-21
B645T04961EDGE BIOLOGICALS INCT04962025-04-21
B645T05771EDGE BIOLOGICALS INCT05772025-04-21
B645T06151EDGE BIOLOGICALS INCT06152025-04-21
B645T06411EDGE BIOLOGICALS INCT06412025-04-21
B645T07111EDGE BIOLOGICALS INCT07112025-04-21

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
B6453P3951EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSJ2025-04-21
B6451R0091EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSJ2025-04-18
B6453P2751EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSJ2025-04-18
B6453P3901EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSJ2025-04-18
B6454P2561EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSJ2025-04-18
B6454P3301EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSJ2025-04-18
B645T08001EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSJ2025-04-18
B645T00041EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSJ2025-04-17
B645T06311EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSJ2025-04-17
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30382902216019BD BBL™ Columbia CNA Agar with 5% SB and BD BBL MacConkey II Agar BD I Plate™BECTON, DICKINSON AND COMPANYJSJ2024-08-23
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05032384139811XLT-4 Selective SupplementOXOID LIMITEDJSJ2024-08-13
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00850056467032OxyPRAS Anaselect Blood Agar plateOxyrase, Inc.JSJ2023-11-30
00850056467049OxyPRAS Plus KVL plateOxyrase, Inc.JSJ2023-11-30
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00850056467070KVL OxyPlateOxyrase, Inc.JSJ2023-11-30
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00850056467094OxyPRAS Plus 3-pack: Brucella, PEA and BBE/KVL Bi-PlateOxyrase, Inc.JSJ2023-11-30
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B088212730010InTray® SAB+PVGBIO-MED DIAGNOSTICS, INC.JSJ2023-10-05
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