InTray™ GC 10-8000

GUDID B08810804

Intended for use in the qualitative detection of oral, rectal and genitourethral Neisseria gonorrhoeae colonization.

BIO-MED DIAGNOSTICS, INC.

Neisseria gonorrhoeae culture isolate identification IVD, kit

• Primary Device ID: B08810804
• NIH Device Record Key: baeb33b4-58fa-41da-87f0-6e6f3ba1dc3f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InTray™ GC
• Version Model Number: 1080
• Catalog Number: 10-8000
• Company DUNS: 605213545
• Company Name: BIO-MED DIAGNOSTICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800) 964-6466
• Email: info@biomeddiagnostics.com
• Phone: +1(800) 964-6466
• Email: info@biomeddiagnostics.com

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	B08810800 [Primary]
HIBCC	B08810802 [Package]; Contains: B08810800; Package: Box [5 Units]; In Commercial Distribution
HIBCC	B08810803 [Package]; Contains: B08810800; Package: Box [10 Units]; In Commercial Distribution
HIBCC	B08810804 [Package]; Contains: B08810800; Package: Box [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K993033

FDA Product Code

• JTY: Culture Media, For Isolation Of Pathogenic Neisseria

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-07-18
• Device Publish Date: 2016-09-21

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