FDA UDI
Not in Commercial Distribution
🇺🇸 United States
ARCHITECT
DI: 00380740003333
·
Model: 2K44-20
·
ABBOTT LABORATORIES
Product Codes
3
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
- ARCHITECT
- Primary DI
- 00380740003333
- Version / Model
- 2K44-20
- Catalog Number
- 02K4420
- Company Name
- ABBOTT LABORATORIES
- Labeler DUNS
- 079226220
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-06-06
- Public Version
- 5
- Public Version Date
- 2024-10-28
- Public Version Status
- Update
- Public Device Record Key
- 57b3e111-0951-48ba-bd88-17af51ca3d99
- Distribution End Date
- 2022-12-31
Device Description
ARCHITECT CA15-3 Reagent Kit
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| JJX | SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED) | Clinical Chemistry | 862.1660 | 1 |
| JIT | CALIBRATOR, SECONDARY | Clinical Chemistry | 862.1150 | 2 |
| MOI | SYSTEM, TEST, IMMUNOLOGICAL, ANTIGEN, TUMOR | Immunology | 866.6010 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60975 | Cancer antigen 15-3 (CA15-3) 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 15-3 (CA15-3), a marker commonly associated with breast cancer, 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 | 00380740003333 | GS1 |
Customer Contacts
- Phone
- +1(877)422-2688
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius