FDA UDI
In Commercial Distribution
🇺🇸 United States
ARCHITECT
DI: 00380740008970
·
Model: 6C06-10
·
Abbott Ireland Diagnostics
Product Codes
5
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ARCHITECT
- Primary DI
- 00380740008970
- Version / Model
- 6C06-10
- Catalog Number
- 06C0610
- Company Name
- Abbott Ireland Diagnostics
- Labeler DUNS
- 985307301
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-11-18
- Public Version
- 4
- Public Version Date
- 2023-12-20
- Public Version Status
- Update
- Public Device Record Key
- 0b056c03-6dbe-43a9-aa87-ec341d07685e
Device Description
ARCHITECT Total PSA Controls
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 |
|---|---|---|---|---|
| MTF | TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER | Unknown | 3 | |
| JJX | SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED) | Clinical Chemistry | 862.1660 | 1 |
| JIS | CALIBRATOR, PRIMARY | Clinical Chemistry | 862.1150 | 2 |
| JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | Clinical Chemistry | 862.2160 | 1 |
| LTJ | PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS | Immunology | 866.6010 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38207 | Total prostate specific antigen (tPSA) IVD, control | A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of total prostate specific antigen (tPSA) in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00380740008970 | GS1 |
Customer Contacts
- Phone
- +1(877)422-2688
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius