Xmatrx® MINI AS1010

GUDID 00810119676306

BIOGENEX LABORATORIES

Microscope slide stainer IVD

• Primary Device ID: 00810119676306
• NIH Device Record Key: c9189382-b3c8-4991-8b7e-c82c4835e957
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Xmatrx® MINI
• Version Model Number: AS1010
• Catalog Number: AS1010
• 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: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810119676306 [Primary]

FDA Product Code

• KEY: Stainer, Tissue, Automated

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: 2023-04-28
• Device Publish Date: 2023-04-20

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