Identity
- Trade Name
- Indiko Plus FDA UDI
- Generic Name
- Multiple clinical chemistry analyser IVD, laboratory FDA UDI
- Device Name
- Clinical Chemistry Analyzer FDA UDI
- Model / Reference
- 864 FDA UDI
- Description
- Clinical Chemistry Analyzer FDA UDI
Identifiers
- Catalog Number
- 98640000 FDA UDI
- Primary DI / UDI-DI
- 06438153001164 FDA UDI
- 510(k) Number
- K110035 FDA UDI
- FDA Product Code
- JJE FDA UDI
- GMDN Term
- Multiple clinical chemistry analyser IVD, laboratory FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2160 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Multiple clinical chemistry analyser IVD, laboratory
Indiko Plus by Thermo Fisher Scientific — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K110035 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Thermo Fisher Scientific
Sources (1)
- FDA UDI dbe31dd3-deb4-46fb-b4fc-8d5f49ec70ae 35 fields · synced May 30, 2026