FDA UDI
In Commercial Distribution
🇺🇸 United States
Alinity
DI: 00380740153953
·
Model: 01R1821
·
Abbott Ireland Diagnostics
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Alinity
- Primary DI
- 00380740153953
- Version / Model
- 01R1821
- Catalog Number
- 01R1821
- Company Name
- Abbott Ireland Diagnostics
- Labeler DUNS
- 985307301
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-01-04
- Public Version
- 2
- Public Version Date
- 2021-12-08
- Public Version Status
- Update
- Public Device Record Key
- 38fcfc98-9be1-42fb-ba8e-9a1ae6616a01
Device Description
Alinity i BRAHMS PCT Reagent Kit 200 Tests
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 |
|---|---|---|---|---|
| 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 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58731 | Procalcitonin (PCT) IVD, kit, chemiluminescent immunoassay | A collection of reagents and other associated materials intended to be used for the quantitative measurement of procalcitonin (PCT) 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 | 00380740153953 | GS1 |
Customer Contacts
- Phone
- +1(877)422-2688
- [email protected]
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- High: 30 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius