Anti-ER (Insite) AM368-5M

GUDID 00850646007075

BIOGENEX LABORATORIES

Estrogen (oestrogen)/progesterone receptor IVD, antibody

• Primary Device ID: 00850646007075
• NIH Device Record Key: 037672be-9110-4b07-8765-65eeff40024d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Anti-ER (Insite)
• Version Model Number: AM368-5M
• Catalog Number: AM368-5M
• Company DUNS: 042697045
• Company Name: BIOGENEX LABORATORIES
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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

Device Dimensions

• Total Volume: 6 Milliliter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850646007075 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K013148

FDA Product Code

• MYA: Immunohistochemistry Antibody Assay, Estrogen Receptor

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

On-Brand Devices [Anti-ER (Insite)]

• 00850646007143: AM368-5MSG
• 00850646007112: MU368-5UC
• 00850646007105: AX368-50D
• 00850646007099: AX368-YCD
• 00850646007082: AM368-10M
• 00850646007075: AM368-5M
• 00850646007068: MU368-UC