FDA Registration
Inactive
🇬🇧 United Kingdom
KIT COBAS LIAT SARS-COV-2/FLU
·
Expires 2025
Products
1
Proprietary Names
16
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Roche Lumira Dx Stirling
- Status
- Inactive
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Manor Farm Business Park
- City
- Manor Loan Stirling
- Country
- GB
Owner / Operator
- Firm Name
- Roche Diagnostics Operations Inc.
- Operator Number
- 9039767
- Address
- 9115 Hague Road
- City
- Indianapolis
- State
- IN
- Postal Code
- 46250
- Country
- US
US Agent
- Business Name
- ROCHE DIAGNOSTICS OPERATIONS INC.
- Contact Name
- Brian Frazier
- Address
- 9115 Hague Rd
- City
- Indianapolis
- State
- IN
- ZIP
- 46256
- Country
- US
- [email protected]
- Phone
- 317 3194485
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Reagents, 2019-Novel Coronavirus Nucleic Acid | QJR | Class N | Unknown | No | 2020-04-23 |
Proprietary Names
KIT COBAS LIAT SARS-COV-2/FLU
cobas® SARS-CoV-2 & Influenza A/B Control Kit
KIT COBAS LIAT SARS-COV-2/FLU CTL
cobas® SARS-CoV-2 & Influenza A/B for use on the cobas® 6800/8800 Systems
KIT COBAS 6800/8800 SARS-COV-2 192T
KIT COBAS 6800/8800 SARS-COV-2 RMC
KIT COBAS 6800/8800 SARS-COV-2/FLU RMC
cobas® SARS-CoV-2 - 480T
KIT COBAS 6800/8800 SARS-COV-2/FLU 384T
cobas® SARS-CoV-2 Quality Control Kit
KIT COBAS 6800/8800 SARS-COV-2 480T
KIT C68/88 SARS-COV2 DUO 192T
KIT C68/88 SARS-COV2 DUO RMC
KIT COBAS 58/68/8800 SARSCOV2FLUV2 192T
KIT COBAS 58/68/8800 SARS-COV-2/FLU RMC
SARS-CoV-2 Ag Test
Establishment Types
Manufacture Medical Device