InTray® DM 22-063-000

GUDID B08820630

An enriched dermatophyte medium used in the detection of dermatophytes from clinical specimens.

BIO-MED DIAGNOSTICS, INC.

Multiple dermatophyte species culture isolate identification IVD, kit

• Primary Device ID: B08820630
• NIH Device Record Key: 5fe6a40a-c01e-4abc-bec4-5aa0d95ac6a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InTray® DM
• Version Model Number: 2063
• Catalog Number: 22-063-000
• 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
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B08820630 [Primary]
HIBCC	B08820632 [Package]; Package: Box [5 Units]; In Commercial Distribution
HIBCC	B08820634 [Package]; 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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-07-18
• Device Publish Date: 2018-09-13

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