2-Compnent DAB Pack HK542-XAKE

GUDID 00850646007365

BIOGENEX LABORATORIES

Immunohistochemistry chromogenic substrate IVD, kit, enzyme immunohistochemistry Immunohistochemistry chromogenic substrate IVD, kit, enzyme immunohistochemistry Immunohistochemistry chromogenic substrate IVD, kit, enzyme immunohistochemistry Immunohistochemistry chromogenic substrate IVD, kit, enzyme immunohistochemistry Immunohistochemistry chromogenic substrate IVD, kit, enzyme immunohistochemistry Immunohistochemistry chromogenic substrate IVD, kit, enzyme immunohistochemistry Immunohistochemistry chromogenic substrate IVD, kit, enzyme immunohistochemistry Immunohistochemistry chromogenic substrate IVD, kit, enzyme immunohistochemistry Immunohistochemistry chromogenic substrate IVD, kit, enzyme immunohistochemistry Immunohistochemistry chromogenic substrate IVD, kit, enzyme immunohistochemistry Immunohistochemistry chromogenic substrate IVD, kit, enzyme immunohistochemistry Immunohistochemistry chromogenic substrate IVD, kit, enzyme immunohistochemistry Immunohistochemistry chromogenic substrate IVD, kit, enzyme immunohistochemistry Immunohistochemistry chromogenic substrate IVD, kit, enzyme immunohistochemistry Immunohistochemistry chromogenic substrate IVD, kit, enzyme immunohistochemistry Immunohistochemistry chromogenic substrate IVD, kit, enzyme immunohistochemistry

• Primary Device ID: 00850646007365
• NIH Device Record Key: 87fae5bb-d9e6-47e0-b5f5-479a13c5d814
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 2-Compnent DAB Pack
• Version Model Number: HK542-XAKE
• Catalog Number: HK542-XAKE
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850646007365 [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

Devices Manufactured by BIOGENEX LABORATORIES

• 00810119675187 - ANTI-PAX5: 2023-05-29
• 00810119675972 - ANTI-HLA-DR: 2023-05-29
• 00810119676061 - Anti- c-Myc: 2023-05-29
• 00810119676221 - LIQUID DAB, CHROMOGEN: 2023-05-29
• 00810119676252 - H.PYLORI: 2023-05-29
• 00850646007327 - AEC (Aminoethylcarbazole): 2023-05-29
• 00850646007334 - AEC Substrate Pack: 2023-05-29
• 00850646007341 - Diluent: 2023-05-29