Aptima
- Primary DI
- 15420045500181
- Brand
- Aptima
- Company
- Hologic, Inc.
- Model
- HIV-1 Qual
- Catalog number
- 302178
- Device description
- PAS to Procleix HIV/HCV. Product Code not required for IVD (BL registration numbers)
- Published
- 2014-08-06
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- true
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 15420045500181 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|
| 15420045500181 | 15420045500181 |
GMDN Terms
| Term | Definition |
|---|
| HIV1 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 in a clinical specimen, using a nucleic acid technique (NAT). |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Storage Environment Temperature | 2 Degrees Celsius | 8 Degrees Celsius | |
Regulatory Flags
- DUNS number
- 050579217
- Device count
- 1
- DM exempt
- true
- Premarket exempt
- false
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| 15420045518131 | Selenia® Dimensions® | ASY-10775-2D | ASY-10775-2D | 2026-03-12 |
| 15420045518148 | Selenia® Dimensions® | ASY-10775-3D | ASY-10775-3D | 2026-03-12 |
| 15420045518155 | Selenia® Dimensions® | ASY-10775-2D-UPS | ASY-10775-2D-UPS | 2026-03-12 |
| 15420045518162 | Selenia® Dimensions® | ASY-10775-3D-UPS | ASY-10775-3D-UPS | 2026-03-12 |
| 15420045518179 | Selenia® Dimensions® | ASY-10775-2D-CN | ASY-10775-2D-CN | 2026-03-12 |
| 15420045518186 | Selenia® Dimensions® | ASY-08483-2D | ASY-08483-2D | 2026-03-12 |
| 15420045518193 | Selenia® Dimensions® | ASY-10775-3D-CN | ASY-10775-3D-CN | 2026-03-12 |
| 15420045518216 | Selenia® Dimensions® | ASY-08483-3D | ASY-08483-3D | 2026-03-12 |
| 15420045518223 | Selenia® Dimensions® | ASY-08483-3D-CN | ASY-08483-3D-CN | 2026-03-12 |
| 15420045518230 | Selenia® Dimensions® | ASY-08483-2D-CN | ASY-08483-2D-CN | 2026-03-12 |
| 15420045518247 | Affirm Prone Biopsy System | PBX-SYS-AFFIRM-3D-CN | PBX-SYS-AFFIRM-3D-CN | 2026-03-12 |
| 15420045518261 | Affirm Prone Biopsy System | PBX-SYS-AFFIRM-2D-CN | PBX-SYS-AFFIRM-2D-CN | 2026-03-12 |
| 15420045518278 | Affirm Prone Biopsy System | ASY-06886-CN | ASY-06886-CN | 2026-03-12 |
| 15420045518285 | Affirm Prone Biopsy System | ASY-09175-CN | ASY-09175-CN | 2026-03-12 |
| 15420045518292 | Affirm Prone Biopsy System | ASY-08832-CN | ASY-08832-CN | 2026-03-12 |
| 15420045516236 | Envision | ASY-14621 | ASY-14621 | 2025-11-13 |
| 15420045516243 | Envision | ASY-14622 | ASY-14622 | 2025-11-13 |
| 15420045516250 | Envision | ASY-14623 | ASY-14623 | 2025-11-13 |
| 15420045516267 | Envision | ASY-14624 | ASY-14624 | 2025-11-13 |
| 15420045516274 | Envision | ASY-14625 | ASY-14625 | 2025-11-13 |
hologic.com