Procleix 301105C

GUDID 15420045500594

FDA Product Code, Supplement Authorization and FDA Listing Number are not required for BLA products.

Hologic, Inc.

HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 15420045500594
• NIH Device Record Key: 3170b840-f816-4eba-9074-ca2703c6e365
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Procleix
• Version Model Number: Ultrio 5K
• Catalog Number: 301105C
• Company DUNS: 050579217
• Company Name: Hologic, Inc.
• Device Count: 1
• 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	15420045500594 [Primary]

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2014-08-06

On-Brand Devices [Procleix]

• 15420045504264: LBL BOX, DPROBE, ULTRIO, 200T, IVD
• 15420045504257: LBL BOX, DPROBE, ULTRIO, 200T, IVD
• 15420045500723: Auto Detect Reagents
• 15420045500716: Assay Fluids
• 15420045500709: Not required for BLA products.
• 15420045500693: FDA Product Code, Supplement Authorization and FDA Listing Number are not required for BLA produ
• 15420045500686: FDA Product Code, Supplement Authorization and FDA Listing Number are not required for BLA produ
• 15420045500679: FDA Product Code, Supplement Authorization and FDA Listing Number are not required for BLA produ
• 15420045500662: FDA Product Code, Supplement Authorization and FDA Listing Number are not required for BLA produ
• 15420045500655: FDA Product Code, Supplement Authorization and FDA Listing Number are not required for BLA produ
• 15420045500648: FDA Product Code, Supplement Authorization and FDA Listing Number are not required for BLA produ
• 15420045500631: FDA Product Code, Supplement Authorization and FDA Listing Number are not required for BLA produ
• 15420045500624: FDA Product Code, Supplement Authorization and FDA Listing Number are not required for BLA produ
• 15420045500617: FDA Product Code, Supplement Authorization and FDA Listing Number are not required for BLA produ
• 15420045500600: FDA Product Code, Supplement Authorization and FDA Listing Number are not required for BLA produ
• 15420045500594: FDA Product Code, Supplement Authorization and FDA Listing Number are not required for BLA produ
• 15420045500587: FDA Product Code, Supplement Authorization and FDA Listing Number are not required for BLA produ
• 15420045500570: FDA Product Code, Supplement Authorization and FDA Listing Number are not required for BLA produ
• 15420045500563: FDA Product Code, Supplement Authorization and FDA Listing Number are not required for BLA produ
• 15420045500556: FDA Product Code, Supplement Authorization and FDA Listing Number are not required for BLA produ
• 15420045500549: FDA Product Code, Supplement Authorization and FDA Listing Number are not required for BLA produ
• 15420045500532: FDA Product Code, Supplement Authorization and FDA Listing Number are not required for BLA produ
• 15420045500525: FDA Product Code, Supplement Authorization and FDA Listing Number are not required for BLA produ
• 15420045500518: FDA Product Code, Supplement Authorization and FDA Listing Number are not required for BLA produ
• 15420045500501: FDA Product Code, Supplement Authorization and FDA Listing Number are not required for BLA produ
• 15420045500495: FDA Product Code, Supplement Authorization and FDA Listing Number are not required for BLA produ
• 15420045500488: FDA Product Code, Supplement Authorization and FDA Listing Number are not required for BLA produ
• 15420045500471: FDA Product Code, Supplement Authorization and FDA Listing Number are not required for BLA produ
• 15420045500464: FDA Product Code, Supplement Authorization and FDA Listing Number are not required for BLA produ
• 15420045500457: FDA Product Code, Supplement Authorization and FDA Listing Number are not required for BLA produ
• 15420045500440: FDA Product Code, Supplement Authorization and FDA Listing Number are not required for BLA produ
• 15420045500433: FDA Product Code, Supplement Authorization and FDA Listing Number are not required for BLA produ
• 15420045500426: FDA Product Code, Supplement Authorization and FDA Listing Number are not required for BLA produ
• 15420045500419: FDA Product Code, Supplement Authorization and FDA Listing Number are not required for BLA produ
• 15420045500402: FDA Product Code, Supplement Authorization and FDA Listing Number are not required for BLA produ
• 15420045500396: FDA Product Code, Supplement Authorization and FDA Listing Number are not required for BLA produ
• 15420045500389: FDA Product Code, Supplement Authorization and FDA Listing Number are not required for BLA produ
• 15420045500372: FDA Product Code, Supplement Authorization and FDA Listing Number are not required for BLA produ
• 15420045500365: FDA Product Code, Supplement Authorization and FDA Listing Number are not required for BLA produ
• 15420045500358: FDA Product Code, Supplement Authorization and FDA Listing Number are not required for BLA produ
• 15420045500341: FDA Product Code, Supplement Authorization and FDA Listing Number are not required for BLA produ
• 15420045500334: FDA Product Code, Supplement Authorization and FDA Listing Number are not required for BLA produ
• 15420045500327: FDA Product Code, Supplement Authorization and FDA Listing Number are not required for BLA produ
• 15420045500310: FDA Product Code, Supplement Authorization and FDA Listing Number are not required for BLA produ