FDA UDI
Not in Commercial Distribution
🇺🇸 United States
ARCHITECT
DI: 00380740105464
·
Model: 2K91-29
·
ABBOTT LABORATORIES
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ARCHITECT
- Primary DI
- 00380740105464
- Version / Model
- 2K91-29
- Catalog Number
- 02K9129
- 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
- 2023-10-02
- Public Version Status
- Update
- Public Device Record Key
- 2d9a1e9c-786e-457f-ac6d-eec64468ba3d
- Distribution End Date
- 2019-01-19
Device Description
ARCHITECT CA19-9XR 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 |
|---|---|---|---|---|
| JIT | CALIBRATOR, SECONDARY | Clinical Chemistry | 862.1150 | 2 |
| JJX | SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED) | Clinical Chemistry | 862.1660 | 1 |
| NIG | SYSTEM, TEST, CARBOHYDRATE ANTIGEN (CA19-9), FOR MONITORING AND MANAGEMENT OF PANCREATIC CANCER | Immunology | 866.6010 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60976 | Cancer antigen 19-9 (CA19-9) 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 19-9 (CA19-9) in a clinical specimen, using a chemiluminescent immunoassay method. CA19-9 is typically used as a marker commonly associated with gastrointestinal, pancreatic, bile duct and gallbladder cancer. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00380740105464 | GS1 |
Customer Contacts
- Phone
- +1(877)422-2688
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K052000 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius