Progensa 302352

GUDID 25420045500775

Hologic, Inc.

Prostate cancer gene 3/prostate specific antigen (PCA3/PSA) mRNA expression IVD, kit, nucleic acid technique (NAT) Prostate cancer gene 3/prostate specific antigen (PCA3/PSA) mRNA expression IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 25420045500775
• NIH Device Record Key: 7c3d4215-5f23-4011-9f4c-66a58cb70f7a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Progensa
• Version Model Number: PCA3 URINE TRANSPORT
• Catalog Number: 302352
• Company DUNS: 050579217
• Company Name: Hologic, Inc.
• Device Count: 50
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	15420045500778 [Unit of Use]
GS1	25420045500775 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P100033

FDA Product Code

• OIE: Urine collection kit (excludes hiv testing)

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: 2014-09-17

On-Brand Devices [Progensa]

• 25420045500775: PCA3 URINE TRANSPORT
• 15420045500822: URINE SPECIMENT TRANSPORT TUBES
• 15420045500815: PCA3 SPECIMEN DILUENT KIT
• 15420045500808: PSA CALIBRATORS AND CONTROLS
• 15420045500792: PCA3 CALIBRATORS AND CONTROLS
• 15420045500785: ASSAY FLUIDS KIT
• 15420045500761: PSA
• 15420045500754: PSA
• 15420045500747: PCA3
• 15420045500730: PCA3