FDA UDI
In Commercial Distribution
🇺🇸 United States
Aptima®
DI: 15420045500136
·
Model: KIT, APTIMA HPV 16 18/45, CALS IVD
·
Hologic, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Aptima®
- Primary DI
- 15420045500136
- Version / Model
- KIT, APTIMA HPV 16 18/45, CALS IVD
- Catalog Number
- 303235
- Company Name
- Hologic, Inc.
- Labeler DUNS
- 050579217
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-07-30
- Public Version
- 3
- Public Version Date
- 2024-06-13
- Public Version Status
- Update
- Public Device Record Key
- 73415f1a-58bd-47fd-9129-5be9752eedc5
Device Description
Aptima® GT HPV 16 18/45 Genotype Assay Calibrators Kit.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OYB | Kit, rna detection, human papillomavirus | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 52765 | Human papillomavirus (HPV) high-risk strain nucleic acid IVD, calibrator | A material that is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid from one or multiple high-risk strains of human papillomavirus (HPV) associated with cervical cancer, which may include types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and/or 68 in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 15420045500136 | GS1 |
Customer Contacts
- Phone
- +1(800)442-9892
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P120007 | 001 |
| P120007 | 002 |
| P120007 | 003 |
| P120007 | 011 |
| P120007 | 018 |
| P120007 | 019 |
| P120007 | 022 |
| P120007 | 025 |
| P120007 | 026 |
| P120007 | 029 |
| P120007 | 030 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius