FDA UDI
In Commercial Distribution
🇺🇸 United States
Aptima®
DI: 15420045514577
·
Model: CMV, CALIBRATOR KIT, APTIMA, IVD
·
Hologic, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Aptima®
- Primary DI
- 15420045514577
- Version / Model
- CMV, CALIBRATOR KIT, APTIMA, IVD
- Catalog Number
- PRD-05075
- 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
- 4
- Public Version Date
- 2025-12-03
- Public Version Status
- Update
- Public Device Record Key
- 5fa9da52-ad49-4250-a029-30e775ecf3f4
Device Description
Aptima® CMV Quant 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 |
|---|---|---|---|---|
| PAB | Cytomegalovirus (cmv) dna quantitative assay | Microbiology | 866.3180 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41764 | Cytomegalovirus (CMV) nucleic acid IVD, calibrator | A material which 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 cytomegalovirus (CMV) in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 15420045514577 | GS1 |
Customer Contacts
- Phone
- +1(800)442-9892
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K243935 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -35 – -15 Degrees Celsius