EDGE BIOLOGICALS INC

GUDID B6454P124

DERMATOPHYTE TEST MEDIUM (DTM) AGAR

EDGE BIOLOGICALS, INC.

Tissue culture/microbiology petri dish Tissue culture/microbiology petri dish Tissue culture/microbiology petri dish Tissue culture/microbiology petri dish Tissue culture/microbiology petri dish Tissue culture/microbiology petri dish Tissue culture/microbiology petri dish Tissue culture/microbiology petri dish Tissue culture/microbiology petri dish Tissue culture/microbiology petri dish Tissue culture/microbiology petri dish Tissue culture/microbiology petri dish Tissue culture/microbiology petri dish Tissue culture/microbiology petri dish Tissue culture/microbiology petri dish Tissue culture/microbiology petri dish Tissue culture/microbiology petri dish, single-use Tissue culture/microbiology petri dish, single-use Tissue culture/microbiology petri dish, single-use Tissue culture/microbiology petri dish, single-use Tissue culture/microbiology petri dish, single-use Tissue culture/microbiology petri dish, single-use Tissue culture/microbiology petri dish, single-use Tissue culture/microbiology petri dish, single-use Tissue culture/microbiology petri dish, single-use Tissue culture/microbiology petri dish, single-use Tissue culture/microbiology petri dish, single-use Tissue culture/microbiology petri dish, single-use Tissue culture/microbiology petri dish, single-use

• Primary Device ID: B6454P124
• NIH Device Record Key: f34160df-916d-4645-87e0-dcd21f9ba237
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EDGE BIOLOGICALS INC
• Version Model Number: 4P124
• Company DUNS: 047927827
• Company Name: EDGE BIOLOGICALS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B6454P124 [Primary]

FDA Product Code

• JSI: Culture Media, Selective And Differential

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-15
• Device Publish Date: 2023-06-07

On-Brand Devices [EDGE BIOLOGICALS INC]

• B6452P075: 2P075
• B6452P009: 2P009
• B645T0721: THIOGLYCOLLATE BROTH THIOGLYCOLLATE BROTH W/O INDICATOR 5ML
• B645T0482: NUTRIENT BROTH 10ML
• B645T0045: BRAIN HEART INFUSION BROTH W/ GLYCEROL 2ML
• B6454P414: THERMAL AGAR
• B6454P320: SABOURAUD DEXTROSE AGAR
• B6454P286: PSEUDOMONAS ISOLATION AGAR
• B6454P202: INHIBITORY MOLD AGAR
• B6454P182: ETA W/ GENTAMICIN AGAR EUGON AGAR W/ GENTAMICIN
• B6454P124: DERMATOPHYTE TEST MEDIUM (DTM) AGAR
• B6454P100: XLT-4 AGAR
• B6454P021: BRAIN HEART INFUSION AGAR W/ GENTAMICIN
• B6454P019: BACILLUS CERUS AGAR
• B6454B070: BILE ESCULIN / BHI 6.5% NACL BI PLATE BILE ESCULIN/BHI WITH Salt biplate
• B6453P276: PEA W/ SHEEP BLOOD AGAR
• B6453P240: MUELLER HINTON AGAR
• B6453P190: HEKTOEN ENTERIC AGAR
• B6453P020: BRAIN HEART INFUSION AGAR
• B6452P425: XLD AGAR
• B6452P380: SALMONELLA-SHIGELLA (SS) AGAR
• B6452P285: PLATE COUNT AGAR
• B6452P210: MANNITOL SALT AGAR
• B6452P070: BILE ESCULIN AGAR
• B6452P069: BISMUTH SULFITE AGAR
• B6451R003: TRYPTIC SOY AGAR W/ LECITHIN & POLYSORBATE 80
• B6451P405: TRYPTIC SOY AGAR
• B6451P265: NUTRIENT AGAR
• B6451P205: MACCONKEY AGAR
• B6451P180: LEVINE EMB AGAR EOSIN METHYLENE BLUE (EMB) AGAR