FDA UDI
In Commercial Distribution
🇺🇸 United States
Alinity
DI: 00380740146269
·
Model: 03R7521
·
Abbott GmbH
Product Codes
1
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Alinity
- Primary DI
- 00380740146269
- Version / Model
- 03R7521
- Catalog Number
- 03R7521
- Company Name
- Abbott GmbH
- Labeler DUNS
- 315786293
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-08-10
- Public Version
- 1
- Public Version Date
- 2020-08-18
- Public Version Status
- New
- Public Device Record Key
- 0768e505-dfff-489e-8680-2c7a41d938c7
Device Description
Alinity i ROMA
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
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ONX | Ovarian adnexal mass assessment score test system | Obstetrics/Gynecology | 866.6050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 54588 | Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassay | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of cancer antigen 125 (CA125), a marker commonly associated with ovarian cancer, in a clinical specimen using a chemiluminescent immunoassay method. | No | Active |
| 56656 | Human epididymis protein 4 (HE4) IVD, kit, chemiluminescent immunoassay | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of human epididymis protein 4 (HE4) ovarian cancer marker in a clinical specimen, using a chemiluminescent immunoassay method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00380740146269 | GS1 |
Customer Contacts
- Phone
- +1(877)422-2688
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K151502 | 000 |