H.PYLORI AM880-5M

GUDID 00810119671875

BIOGENEX LABORATORIES

Multiple gastrointestinal disease marker IVD, reagent Multiple gastrointestinal disease marker IVD, reagent Multiple gastrointestinal disease marker IVD, reagent Multiple gastrointestinal disease marker IVD, reagent Multiple gastrointestinal disease marker IVD, reagent Multiple gastrointestinal disease marker IVD, reagent Multiple gastrointestinal disease marker IVD, reagent Multiple gastrointestinal disease marker IVD, reagent Multiple gastrointestinal disease marker IVD, reagent Multiple gastrointestinal disease marker IVD, reagent Multiple gastrointestinal disease marker IVD, reagent Multiple gastrointestinal disease marker IVD, reagent Multiple gastrointestinal disease marker IVD, reagent Multiple gastrointestinal disease marker IVD, reagent Multiple gastrointestinal disease marker IVD, reagent

• Primary Device ID: 00810119671875
• NIH Device Record Key: 86ea275c-8017-4a1c-83b8-9f008273d601
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: H.PYLORI
• Version Model Number: AM880-5M
• Catalog Number: AM880-5M
• Company DUNS: 042697045
• Company Name: BIOGENEX LABORATORIES
• 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: false
• 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) 421-4149
• Email: support@biogenex.com
• Phone: +1 (800) 421-4149
• Email: support@biogenex.com
• Phone: +1 (800) 421-4149
• Email: support@biogenex.com
• Phone: +1 (800) 421-4149
• Email: support@biogenex.com
• Phone: +1 (800) 421-4149
• Email: support@biogenex.com
• Phone: +1 (800) 421-4149
• Email: support@biogenex.com
• Phone: +1 (800) 421-4149
• Email: support@biogenex.com
• Phone: +1 (800) 421-4149
• Email: support@biogenex.com
• Phone: +1 (800) 421-4149
• Email: support@biogenex.com
• Phone: +1 (800) 421-4149
• Email: support@biogenex.com
• Phone: +1 (800) 421-4149
• Email: support@biogenex.com
• Phone: +1 (800) 421-4149
• Email: support@biogenex.com
• Phone: +1 (800) 421-4149
• Email: support@biogenex.com
• Phone: +1 (800) 421-4149
• Email: support@biogenex.com
• Phone: +1 (800) 421-4149
• Email: support@biogenex.com

Device Dimensions

• Total Volume: 6 Milliliter
• Total Volume: 6 Milliliter
• Total Volume: 6 Milliliter
• Total Volume: 6 Milliliter
• Total Volume: 6 Milliliter
• Total Volume: 6 Milliliter
• Total Volume: 6 Milliliter
• Total Volume: 6 Milliliter
• Total Volume: 6 Milliliter
• Total Volume: 6 Milliliter
• Total Volume: 6 Milliliter
• Total Volume: 6 Milliliter
• Total Volume: 6 Milliliter
• Total Volume: 6 Milliliter
• Total Volume: 6 Milliliter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store at 2-8°C
• Special Storage Condition, Specify: Between 0 and 0 *Store at 2-8°C
• Special Storage Condition, Specify: Between 0 and 0 *Store at 2-8°C
• Special Storage Condition, Specify: Between 0 and 0 *Store at 2-8°C
• Special Storage Condition, Specify: Between 0 and 0 *Store at 2-8°C
• Special Storage Condition, Specify: Between 0 and 0 *Store at 2-8°C
• Special Storage Condition, Specify: Between 0 and 0 *Store at 2-8°C
• Special Storage Condition, Specify: Between 0 and 0 *Store at 2-8°C
• Special Storage Condition, Specify: Between 0 and 0 *Store at 2-8°C
• Special Storage Condition, Specify: Between 0 and 0 *Store at 2-8°C
• Special Storage Condition, Specify: Between 0 and 0 *Store at 2-8°C
• Special Storage Condition, Specify: Between 0 and 0 *Store at 2-8°C
• Special Storage Condition, Specify: Between 0 and 0 *Store at 2-8°C
• Special Storage Condition, Specify: Between 0 and 0 *Store at 2-8°C
• Special Storage Condition, Specify: Between 0 and 0 *Store at 2-8°C

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810119671875 [Primary]

FDA Product Code

• MVU: Reagents, Specific, Analyte

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: 2023-05-19
• Device Publish Date: 2023-05-11

On-Brand Devices [H.PYLORI]

• 00810119671875: AM880-5M
• 00810119679321: AY880-YCD
• 00810119676252: AM880-10M