PRAS Oral Treponeme Enrichment Broth (OTEB) AS-603

GUDID 00810048901609

AS-603 Oral Treponeme Enrichment Broth (OTEB) is an enriched non-selective medium used for the isolation, cultivation, and maintenance of Treponema spp. from clinical specimens. Pre-reduced anaerobically sterilized (PRAS). 7 mL fill volume. 16 x 100 mm hungate-capped tube. Slightly turbid light yellow liquid. 10 tubes per pack.

ANAEROBE SYSTEMS

Enriched broth culture medium IVD

• Primary Device ID: 00810048901609
• NIH Device Record Key: 5d5664fd-9474-461e-87eb-a6c2e6dd2245
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRAS Oral Treponeme Enrichment Broth (OTEB)
• Version Model Number: AS-603
• Catalog Number: AS-603
• Company DUNS: 021192653
• Company Name: ANAEROBE SYSTEMS
• Device Count: 10
• 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

Customer Support Contacts

• Phone: 1-800-443-3108
• Email: customerservice@anaerobesystems.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810048900251 [Primary]
GS1	00810048901609 [Unit of Use]

FDA Product Code

• KZI: Culture Media, Enriched

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: 2020-05-11
• Device Publish Date: 2020-05-01

On-Brand Devices [PRAS Oral Treponeme Enrichment Broth (OTEB)]

• 00810048900275: AS-6035 Oral Treponeme Enrichment Broth (OTEB) is an enriched non-selective medium used for the
• 00810048900268: AS-6032 Oral Treponeme Enrichment Broth (OTEB) is an enriched non-selective medium used for the
• 00810048901609: AS-603 Oral Treponeme Enrichment Broth (OTEB) is an enriched non-selective medium used for the i