PSA (EP109) Rabbit Monoclonal Primary Antibody

GUDID 00841683119890

CELL MARQUE CORPORATION

Prostate-specific membrane antigen (PSMA) IVD, antibody

• Primary Device ID: 00841683119890
• NIH Device Record Key: 7256b6c1-8dab-4e7e-864d-845213285ae9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PSA (EP109) Rabbit Monoclonal Primary Antibody
• Version Model Number: 324R-14
• Company DUNS: 025048773
• Company Name: CELL MARQUE CORPORATION
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841683119890 [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: 2022-12-15
• Device Publish Date: 2022-12-07

On-Brand Devices [PSA (EP109) Rabbit Monoclonal Primary Antibody]

• 00841683144045: 324R-15
• 00841683144038: 324R-17
• 00841683119890: 324R-14
• 00841683119647: 324R-16
• 00841683119609: 324R-18