Procleix 301175
GUDID 15420045500709
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 | 15420045500709 |
| NIH Device Record Key | 95bbe532-bcb2-4a13-ba95-180890b064e5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Procleix |
| Version Model Number | Procleix System Fluid Preservative |
| Catalog Number | 301175 |
| 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 |
Customer Support Contacts
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 15420045500709 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- BK060021
FDA Product Code
| MZA | TEST,EQUIPMENT,AUTOMATED BLOODBORNE PATHOGEN |
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 | 2018-04-06 |
| 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 |
Trademark Results [Procleix]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PROCLEIX 78745185 3150993 Live/Registered |
GRIFOLS WORLDWIDE OPERATIONS LIMITED 2005-11-02 |
 PROCLEIX 75819361 2649890 Live/Registered |
GRIFOLS WORLDWIDE OPERATIONS LIMITED 1999-10-12 |
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