InTray DM-FungID 21-593-001

GUDID B08815934

InTray® DM-FungID™ is an enriched dermatophyte medium used to aid in the detection of dermatophytes from clinical specimens with mixed micobiota.

BIO-MED DIAGNOSTICS, INC.

Multiple dermatophyte species culture isolate identification IVD, kit

• Primary Device ID: B08815934
• NIH Device Record Key: 4095c25a-987f-4304-bff3-b0833b2a3606
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InTray DM-FungID
• Version Model Number: 1593
• Catalog Number: 21-593-001
• Company DUNS: 605213545
• Company Name: BIO-MED DIAGNOSTICS, 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: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• 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 18 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B08815930 [Primary]
HIBCC	B08815932 [Package]; Contains: B08815930; Package: box [5 Units]; In Commercial Distribution
HIBCC	B08815934 [Package]; Contains: B08815930; Package: Box [20 Units]; In Commercial Distribution

FDA Product Code

• JSI: Culture Media, Selective And Differential

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-02-18
• Device Publish Date: 2020-02-10

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