FDA UDI
In Commercial Distribution
🇺🇸 United States
APTIMA
DI: 15420045514584
·
Model: CMV, CONTROLS KIT, APTIMA, IVD
·
Hologic, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- APTIMA
- Primary DI
- 15420045514584
- Version / Model
- CMV, CONTROLS KIT, APTIMA, IVD
- Catalog Number
- PRD-05076
- Company Name
- Hologic, Inc.
- Labeler DUNS
- 050579217
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-06-01
- Public Version
- 1
- Public Version Date
- 2022-06-09
- Public Version Status
- New
- Public Device Record Key
- 18ce46ad-8461-431b-b917-b5baa7e92849
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| PAB | Cytomegalovirus (cmv) dna quantitative assay | Microbiology | 866.3180 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41761 | Cytomegalovirus (CMV) nucleic acid IVD, control | A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid from cytomegalovirus (CMV) in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 15420045514584 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P210029 | 000 |