FDA Registration
Active
🇺🇸 United States
ARCHITECT BRAHMS PCT Reagent Kit (LN 6P22-27, 6P22-37, 6P22-25, 6P22-35)
Reg #: 1181121
·
FEI: 1181121
·
Expires 2025
Products
5
Proprietary Names
4
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- Fisher Diagnostics
- Registration Number
- 1181121
- FEI Number
- 1181121
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 8365 VALLEY PIKE
- City
- MIDDLETOWN
- State
- VA
- ZIP
- 22645
- Country
- US
Regulatory Submissions
- 510(k) Number
- K170652
Owner / Operator
- Firm Name
- Thermo Fisher Scientific
- Operator Number
- 2517925
- Address
- 168 Third Avenue, --
- City
- Waltham
- State
- MA
- Postal Code
- 02451
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens | PMT | Class 2 | Microbiology | No | 2017-07-25 |
| Calibrator, Secondary | JIT | Class 2 | Clinical Chemistry | No | 2017-07-25 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2017-07-25 |
| Procalcitonin Assay | PRI | Class 2 | Microbiology | No | 2017-07-25 |
| Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission | PTF | Class 2 | Microbiology | No | 2017-07-25 |
Proprietary Names
ARCHITECT BRAHMS PCT Reagent Kit (LN 6P22-27, 6P22-37, 6P22-25, 6P22-35)
Alinity i BRAHMS PCT Reagent Kit (LN 01R1821)
ARCHITECT BRAHMS PCT Controls (LN 6P22-10)
ARCHITECT BRAHMS PCT Calibrators (LN 6P22-01)
Establishment Types
Manufacture Medical Device