Procleix
- Primary DI
- 15420045500716
- Brand
- Procleix
- Company
- Hologic, Inc.
- Model
- Assay Fluids
- Catalog number
- 301116
- 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 |
|---|---|---|---|---|
| 15420045500716 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|---|
| 15420045500716 | 15420045500716 |
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 |
|---|---|---|---|---|
| 05420045503888 | SecurMark | SMARK-U-SS1 | SMARK-U-SS1 | 2015-09-04 |
| 05420045503895 | SecurMark | SMARK-U-SS2 | SMARK-U-SS2 | 2015-09-04 |
| 05420045503901 | SecurMark | SMARK-U-SS3 | SMARK-U-SS3 | 2015-09-04 |
| 15420045511859 | Unifi Workspace | Unifi Workspace V1.0 | 2019-08-09 | |
| 15420045515307 | Acessa ProVu System | 7100 | 7100 | 2023-05-16 |
| 15420045515314 | Acessa ProVu System | MS-06-0171 | MS-06-0171 | 2023-05-16 |
| 15420045515284 | Acessa ProVu System | 5200 | 5200 | 2022-11-08 |
| 15420045513983 | BioZorb | F0202 | F0202 | 2021-04-21 |
| 15420045513990 | BioZorb | F0203 | F0203 | 2021-04-21 |
| 15420045514003 | BioZorb | F0303 | F0303 | 2021-04-21 |
| 15420045514010 | BioZorb | F0304 | F0304 | 2021-04-21 |
| 15420045514027 | BioZorb | F0221 | F0221 | 2021-04-21 |
| 15420045514034 | BioZorb | F0231 | F0231 | 2021-04-21 |
| 15420045514041 | BioZorb | F0331 | F0331 | 2021-04-21 |
| 15420045514058 | BioZorb | F0404 | F0404 | 2021-04-21 |
| 15420045514065 | BioZorb | F0405 | F0405 | 2021-04-21 |
| 15420045512634 | Unifi Workspace | Unifi Workspace V1.0 | 2020-09-21 | |
| 15420045500020 | Selenia Dimensions C-View Software | C-View | SW-03052 | 2014-09-05 |
| 15420045504561 | ATEC Introducer | AI090920 | AI090920 | 2016-08-11 |
| 15420045504578 | ATEC Introducer | AI091220 | AI091220 | 2016-08-11 |