FDA UDI
In Commercial Distribution
🇺🇸 United States
ARCHITECT
DI: 00380740156435
·
Model: 07K0041
·
ABBOTT LABORATORIES
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ARCHITECT
- Primary DI
- 00380740156435
- Version / Model
- 07K0041
- Catalog Number
- 07K0041
- Company Name
- ABBOTT LABORATORIES
- Labeler DUNS
- 079226220
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-03-03
- Public Version
- 3
- Public Version Date
- 2023-09-04
- Public Version Status
- Update
- Public Device Record Key
- 97ebcca3-0169-4db3-ab23-916016faa9e8
Device Description
Quantia Lipoprotein(a)
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- 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
- 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 |
|---|---|---|---|---|
| DFC | LIPOPROTEIN, LOW-DENSITY, ANTIGEN, ANTISERUM, CONTROL | Immunology | 866.5600 | 2 |
| JJX | Single (specified) analyte controls (assayed and unassayed) | Clinical Chemistry | 862.1660 | 1 |
| JIS | Calibrator, primary | Clinical Chemistry | 862.1150 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 53438 | Lipoprotein A IVD, kit, nephelometry/turbidimetry | A collection of reagents and other associated materials intended to be used for the quantitative measurement of lipoprotein A lipid in a clinical specimen, using a nephelometry/turbidimetry method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00380740156435 | GS1 |
Customer Contacts
- Phone
- +1(877)422-2688
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K050487 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- High: 29 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius