FDA UDI
In Commercial Distribution
🇺🇸 United States
Nano-CheckTM COVID-19 IgG/IgM Antibody Test
DI: 00895160002663
·
Model: MD8145
·
NANO-DITECH CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
20
Basic Information
- Brand Name
- Nano-CheckTM COVID-19 IgG/IgM Antibody Test
- Primary DI
- 00895160002663
- Version / Model
- MD8145
- Company Name
- NANO-DITECH CORPORATION
- Labeler DUNS
- 126544316
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2020-04-10
- Public Version
- 3
- Public Version Date
- 2023-06-29
- Public Version Status
- Update
- Public Device Record Key
- 38899c11-c8db-46bd-993b-c54e7eb35130
Device Description
A in vitro diagnostic test for the qualitative detection of IgG/IgM antibodies against SARS-CoV-2 virus using human blood/serum/plasma samples.
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 |
|---|---|---|---|---|
| QKO | Reagent, Coronavirus Serological | Unknown | N |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64756 | SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical | A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies to severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2), the causative agent of coronavirus disease (COVID-19), in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 10895160002660 | GS1 | ||||
| Primary | 00895160002663 | GS1 |
Customer Contacts
- Phone
- 1-609-409-3300
- [email protected]