ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0
Abbott Diagnostics Scarborough, Inc. · Microbiology
Open FDA's page for this record- Third party flag
- N
- City
- Scarborough
- Advisory committee description
- Microbiology
- Address 1
- 10 Southgate Rd.
- Statement or summary
- Summary
- Product code
- OCC
- Zip code
- 04074
- Applicant
- Abbott Diagnostics Scarborough, Inc.
- Decision date
- 2026-08-31
- Decision code
- SESE
- Country code
- US
- Device name
- ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0
- Advisory committee
- MI
- Contact
- Stephanie Rose
- K number
- K262747
- State
- ME
- Date received
- 2026-08-03
- Review advisory committee
- MI
- Postal code
- 04074
- Decision description
- Substantially Equivalent
- Clearance type
- Special
- Harmonized identifiers (openFDA)
- Device name
- Respiratory Virus Panel Nucleic Acid Assay System
- Medical specialty description
- Microbiology
- Regulation number
- 866.3980
- Device class
- 2
- Registration number
- 3010749841, 2024800, 3010770794, 3016838963, 3003018722, 3004530258, 3003795116, 3019946577, 9610126, 3005248192, 1650733, 3005360469, 3002773840, 3007799234, 3002777243, 3003030793, 2243471, 3021140368, 3029059580, 3012494290, 3004141078, 1221359, 2023365, 1528450, 3023372670, 3008632402, 9681630, 3009613136, 3006198300, 3006028115, 3013019728, 3023999024, 3038610665
- FEI number
- 3010749841, 2024800, 3010770794, 3016838963, 3002806559, 3003018722, 3004530258, 3003795116, 3019946577, 3005248192, 3002773840, 3007799234, 3002777243, 3003030793, 2243471, 3021140368, 3029059580, 3002524000, 3012494290, 3004141078, 1221359, 2023365, 3023372670, 3008632402, 3005670738, 3002808845, 3009613136, 3006198300, 3006028115, 3013019728, 3023999024, 3038610665, 1000122536