FDA Registration
Active
🇮🇪 Ireland
Multichem P SP41PA, 05P81-10
Reg #: 3008156187
·
FEI: 3008156187
·
Expires 2025
Products
1
Proprietary Names
31
Establishment Types
4
Classifications
1
Registration Details
- Registration Name
- TECHNO-PATH MANUFACTURING LTD.
- Registration Number
- 3008156187
- FEI Number
- 3008156187
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Fort Henry Business Park
- City
- Ballina Tipperary
- Country
- IE
Owner / Operator
- Firm Name
- Techno-path Manufacturing Ltd.
- Operator Number
- 10030933
- Address
- Fort Henry Business Park
- City
- Ballina
- State
- Tipperary
- Postal Code
- V94FF1P
- Country
- IE
US Agent
- Business Name
- LGC Clinical Diagnostics, INC.
- Contact Name
- Wais Osmani
- Address
- 37 Birch St
- City
- Milford
- State
- MA
- ZIP
- 01757
- Country
- US
- [email protected]
- Phone
- 774 5735689
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | Class 1 | Clinical Chemistry | No | 2022-08-26 |
Proprietary Names
Multichem P SP41PA, 05P81-10
Multichem S Plus Assayed Alinity 08P88-10/11/12
Multichem D-Dimer Assayed DM900A, DM900MA, DM901A, DM902A
Multichem IA Plus IA310A, IA311A, IA312A, IA313A, 05P76-10, 08P86-10, IA321A, IA322A, IA323A
Multichem LPS 06V83-10
Multichem IA Assayed IA300A, IA301A, IA302A, IA303A
Multichem AMH Assayed AM500A/AM500MA, AM501A, AM502A, AM503A
Multichem IA Plus 09339841190, 09339850190, 09339825190
Multichem AE Trilevel Assayed AE610A, AE611A, AE612A, AE613A
Multichem MS Free TDMs 10162066190, 10162074190
Multichem S Plus 09339817190, 09339795190, 09339809190
Multichem AE Assayed Bi Level AE600A, AE601A, AE602A
Multichem MS TDMs 09922571190, 09922580190
Multichem hsTn Assayed HS301A/MA
Multichem U Assayed Alinity 08P89-10
Multichem IA Speciality Assayed BP300A/BP301A/BP302A/BP303A
Multichem U 09339876190, 09339868190
Multichem S Plus CH100PLA, CH101PLA, CH102PLA, CH103PLA, CH110PLA5, CH111PLA5, CH112PLA5, CH113PLA
Multichem S Assayed CH101/102/103A & CH101/102/103A5
Multichem hsTn Assayed 04W26-10
Multichem MS Steroids 09922512190, 09922547190
Multichem A1c HB000A, HB001A, HB002A, HB000M, 04V06-10
Multichem CSF Assayed CF100A, CF101A, CF102A
Multichem MS VitD 09922555190, 09922563190
Multichem P Assayed Alinity 08P90-10
Multichem WBT WB000A, 05P77-10, 04S16-10
Multichem P 09339884190
Multichem S Plus 05P78-10, 05P78-11, 05P78-12
Multichem NB Assayed NB800A
Multichem U UC201A.10, UC202A.10, 05P80-10
Multichem MS ISDs 09922598190, 09922601190
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device
Manufacture Medical Device