HPV 14 PROBE PR251-YAD

GUDID 00810119677228

BIOGENEX LABORATORIES

Human papillomavirus (HPV) antigen IVD, antibody

• Primary Device ID: 00810119677228
• NIH Device Record Key: 4f0e7bbc-1a80-4439-8a66-735695d226c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HPV 14 PROBE
• Version Model Number: PR251-YAD
• Catalog Number: PR251-YAD
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810119677228 [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: 2023-05-26
• Device Publish Date: 2023-05-18

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