FDA UDI
In Commercial Distribution
🇺🇸 United States
Nano-CheckTM AMI 3 in 1
DI: 00895160002090
·
Model: CD301S
·
NANO-DITECH CORPORATION
Product Codes
3
GMDN Terms
1
Identifiers
2
Pkg Device Count
20
Basic Information
- Brand Name
- Nano-CheckTM AMI 3 in 1
- Primary DI
- 00895160002090
- Version / Model
- CD301S
- Catalog Number
- CD301S
- Company Name
- NANO-DITECH CORPORATION
- Labeler DUNS
- 126544316
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2016-09-14
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 394b6b4e-f109-4b6d-ae00-a3c0ea0bea6d
Device Description
In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I, Myoglobin and Creatine kinase MB in human serum and plasma
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| MMI | Immunoassay Method, Troponin Subunit | Clinical Chemistry | 862.1215 | 2 |
| JHT | Chromatographic Separation, Cpk Isoenzymes | Clinical Chemistry | 862.1215 | 2 |
| DDR | Myoglobin, Antigen, Antiserum, Control | Immunology | 866.5680 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47399 | Multiple cardiac marker IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of one or a combination of cardiac markers in a clinical specimen. These cardiac markers 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 | 00895160002090 | GS1 | ||||
| Unit of Use | 10895160002097 | GS1 |
Customer Contacts
- Phone
- 609-409-3300
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K050975 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 30 Degrees Celsius