Procleix
- Primary DI
- 15420045500433
- Brand
- Procleix
- Company
- Hologic, Inc.
- Model
- Ultrio Plus 5K
- Catalog number
- 302574
- Device description
- FDA Product Code, Supplement Authorization and FDA Listing Number are not required for BLA products.
- Published
- 2014-08-06
- Public version status
- Update
- Distribution status
- Not in Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Single use
- true
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 15420045500433 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|---|
| 15420045500433 | 15420045500433 |
GMDN Terms#
| Term | Definition |
|---|---|
| HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of human immunodeficiency virus 1 (HIV1) nucleic acid, Hepatitis C virus nucleic acid and/or Hepatitis B virus nucleic acid in a clinical specimen, using a nucleic acid technique (NAT). |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 050579217
- Device count
- 1
- DM exempt
- true
- Kit
- true
- Lot or batch
- true
- Expiration date on label
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 25420045516691 | RESPDIRECT™ | RESPDIRECT COLLECTION KIT, US-KIT, BOX | PRD-07788 | 2023-08-14 |
| 00850346007030 | CoolSeal™ Trinity | CSL-TR105-30 | CSL-TR105-30 | 2020-10-13 |
| 00850346007047 | CoolSeal™ Trinity | CSL-TR105-37 | CSL-TR105-37 | 2020-10-13 |
| 00850346007061 | CoolSeal™ Trinity | CSL-TR105-44 | CSL-TR105-44 | 2020-10-13 |
| 00850346007092 | CoolSeal™ Reveal | CSL-RV105-10 | CSL-RV105-10 | 2021-05-19 |
| 00850346007085 | CoolSeal™ Mini | CSL-MN103-20 | CSL-MN103-20 | 2020-10-13 |
| 15420045500372 | Procleix | Ultrio Plus 1K | 302573 | 2014-08-06 |
| 15420045500389 | Procleix | Ultrio Plus 1K | 302573 | 2014-08-06 |
| 15420045500396 | Procleix | Ultrio Plus 1K | 302573 | 2014-08-06 |
| 15420045500402 | Procleix | Ultrio Plus 1K | 302573 | 2014-08-06 |
| 15420045500419 | Procleix | Ultrio Plus 5K | 302574 | 2014-08-06 |
| 15420045500426 | Procleix | Ultrio Plus 5K | 302574 | 2014-08-06 |
| 15420045500440 | Procleix | Ultrio Plus 5K | 302574 | 2014-08-06 |
| 15420045500457 | Procleix | Ultrio Plus 5K | 302574 | 2014-08-06 |
| 15420045500464 | Procleix | Ultrio Plus, HIV-1 D-Probes | 302571 | 2014-08-06 |
| 15420045500471 | Procleix | Ultrio Plus HBV D-Probes | 302576 | 2014-08-06 |
| 15420045500488 | Procleix | Ultrio Plus HCV D-Probes | 302577 | 2014-08-06 |
| 15420045500495 | Procleix | Ultrio Plus TIGRIS Controls | 302572 | 2014-08-06 |
| 15420045500501 | Procleix | Ultrio Plus Calibrators | 302575 | 2014-08-06 |
| 15420045500518 | Procleix | Ultrio Plus Negative Calibrators | 303260 | 2014-08-06 |