InPouch® TVC Subculture 21-051-001

GUDID B08810510

A highly selective growth medium which maintains viable Trichomonas vaginalis cultures (positive controls) for up to seven (7) days.

BIO-MED DIAGNOSTICS, INC.

Differential/selective broth culture medium IVD

• Primary Device ID: B08810510
• NIH Device Record Key: d7da8131-cd0b-4913-aaa8-5f1b52e82ff6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InPouch® TVC Subculture
• Version Model Number: 1051
• Catalog Number: 21-051-001
• 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
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• 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	B08810510 [Primary]
HIBCC	B08810513 [Package]; Package: Box [10 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: 2019-05-07
• Device Publish Date: 2018-09-12

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