Diluent HK157-5KE

GUDID 00850646007358

BIOGENEX LABORATORIES

Buffered sample diluent IVD, automated/semi-automated system

• Primary Device ID: 00850646007358
• NIH Device Record Key: 7600291c-dcf4-4611-b9a5-9f9bbd8a0ca3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Diluent
• Version Model Number: HK157-5KE
• Catalog Number: HK157-5KE
• 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
• 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

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
• 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	00850646007358 [Primary]

FDA Product Code

• NJT: Immunohistochemistry Reagents And Kits

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: 2023-05-29
• Device Publish Date: 2023-05-19

On-Brand Devices [Diluent]

• 00850646007358: HK157-5KE
• 00850646007341: HK156-5KE
• 00810119678591: HK157-5K
• 00810119678508: HK165-5K
• 00810119677006: HK156-5K