InTray® COLOREX Yeast 21-113-001

GUDID B08811134

For isolation and differentiation of major clinically significant Candida species. Suitable for direct streaking of samples from skin,sputum, urine or

BIO-MED DIAGNOSTICS, INC.

Multiple Candida/yeast species culture isolate identification IVD, kit

• Primary Device ID: B08811134
• NIH Device Record Key: 778b0a3a-2386-49bf-83d5-86d081c425b8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InTray® COLOREX Yeast
• Version Model Number: 1113
• Catalog Number: 21-113-001
• 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 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	B08811130 [Primary]
HIBCC	B08811132 [Package]; Contains: B08811130; Package: Box [5 Units]; In Commercial Distribution
HIBCC	B08811134 [Package]; Contains: B08811130; 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: 2018-10-15
• Device Publish Date: 2018-09-13

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