FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Alere Triage®
DI: 00899722002719
·
Model: 97000HSEU
·
ALERE SAN DIEGO, INC.
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Alere Triage®
- Primary DI
- 00899722002719
- Version / Model
- 97000HSEU
- Catalog Number
- 97000HSEU
- Company Name
- ALERE SAN DIEGO, INC.
- Labeler DUNS
- 194854949
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-26
- Public Version
- 3
- Public Version Date
- 2023-08-23
- Public Version Status
- Update
- Public Device Record Key
- 1e4466fe-b315-4263-a507-8a745b786660
- Distribution End Date
- 2017-10-03
Device Description
Alere Triage® Cardiac Panel
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| DDR | Myoglobin, Antigen, Antiserum, Control | Immunology | 866.5680 | 2 |
| MMI | Immunoassay Method, Troponin Subunit | Clinical Chemistry | 862.1215 | 2 |
| JHX | Fluorometric Method, Cpk Or Isoenzymes | Clinical Chemistry | 862.1215 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47384 | Multiple cardiac marker IVD, kit, fluorescent immunoassay | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or a combination of cardiac markers in a clinical specimen, using a fluorescent immunoassay method. Cardiac markers to be assayed may include B-type natriuretic protein, D-dimer, creatine kinase myocardial isoenzyme (CKMB), myoglobin, myeloperoxidase (MPO), fatty acid binding protein (FABP), glycogen phosphorylase isoenzyme BB (GPBB), troponin I and/or troponin T. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00899722002719 | GS1 |
Customer Contacts
- Phone
- +18773088287
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius