FDA UDI
In Commercial Distribution
🇺🇸 United States
ARCHITECT
DI: 00380740138905
·
Model: 06P2201
·
Abbott GmbH
Product Codes
5
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ARCHITECT
- Primary DI
- 00380740138905
- Version / Model
- 06P2201
- Catalog Number
- 06P2201
- Company Name
- Abbott GmbH
- Labeler DUNS
- 315786293
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-08-16
- Public Version
- 4
- Public Version Date
- 2020-06-22
- Public Version Status
- Update
- Public Device Record Key
- e351b4dc-f506-4af7-9b0d-27136ac2d0fa
Device Description
ARCHITECT B.R.A.H.M.S PCT Calibrators
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
- Yes
- 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 |
| PMT | Device to detect and measure procalcitonin (PCT) in human clinical specimens | Microbiology | 866.3215 | 2 |
| PRI | Procalcitonin assay | Microbiology | 866.3215 | 2 |
| PTF | Assay to measure PCT to aid in the risk assessment of critically ill patients on their first day of ICU admission | Microbiology | 866.3215 | 2 |
| JIT | Calibrator, secondary | Clinical Chemistry | 862.1150 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 54314 | Procalcitonin (PCT) IVD, calibrator | A material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of procalcitonin (PCT) in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00380740138905 | GS1 |
Customer Contacts
- Phone
- +1(877)422-2688
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K170652 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- High: -10 Degrees Celsius