Nano-Check COVID-19 Antigen Test
Nano-Ditech Corporation · Microbiology
Open FDA's page for this record- Third party flag
- N
- City
- Cranbury
- Advisory committee description
- Microbiology
- Address 1
- 259 Prospect Plains Rd., Bldg. K.
- Statement or summary
- Summary
- Product code
- QVF
- Zip code
- 08512
- Applicant
- Nano-Ditech Corporation
- Decision date
- 2024-01-23
- Decision code
- SESE
- Country code
- US
- Device name
- Nano-Check COVID-19 Antigen Test
- Advisory committee
- MI
- Contact
- James B Chang
- K number
- K231187
- State
- NJ
- Date received
- 2023-04-26
- Review advisory committee
- MI
- Postal code
- 08512
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings
- Medical specialty description
- Microbiology
- Regulation number
- 866.3982
- Device class
- 2
- Registration number
- 3002792284, 3008517993, 3007886372, 3031823359, 3033751096, 3032562, 3006948883, 3004635103, 2030538, 2024674, 3033507883, 3021090658, 3009238284, 1119779, 3007606081, 3005174594, 3023322455, 3034405508, 3026664926, 3018786392
- FEI number
- 3002792284, 3008517993, 3007886372, 3031823359, 3033751096, 3006948883, 3004635103, 2024674, 3033507883, 3002606748, 3021090658, 3009238284, 1119779, 3007606081, 3005174594, 3023322455, 3034405508, 3026664926, 3018786392, 1000520007