InTray® TSA 21-443-001

GUDID B08814434

A non-selective medium used for isolation, cultivation and enumeration of non-fastidious and fastidious microorganisms. The device is designed to interface directly with standard methods for bacterial testing of water samples using the Membrane Filter (MF) Technique.

BIO-MED DIAGNOSTICS, INC.

Basic/simple nutrient agar culture medium IVD

• Primary Device ID: B08814434
• NIH Device Record Key: 32b70c88-7938-4f90-b22c-93d5a12bd56f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InTray® TSA
• Version Model Number: 1443
• Catalog Number: 21-443-001
• 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	B08814430 [Primary]
HIBCC	B08814432 [Package]; Contains: B08814430; Package: Box [5 Units]; In Commercial Distribution
HIBCC	B08814434 [Package]; Contains: B08814430; Package: Box [20 Units]; In Commercial Distribution

FDA Product Code

• JSG: Culture Media, Non-Selective And Non-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: 3
• Public Version Date: 2019-06-07
• Device Publish Date: 2018-09-12

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