Identity
- Trade Name
- Lumipulse G TSH-III Calibrators FDA UDI
- Generic Name
- Thyroid stimulating hormone (TSH) IVD, calibrator FDA UDI
- Model / Reference
- 231135 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04987270231135 FDA UDI
- FDA Product Code
- JIT FDA UDI
- GMDN Term
- Thyroid stimulating hormone (TSH) IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1150 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Lumipulse G TSH-III Calibrators by Fujirebio Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Fujirebio Inc.
Sources (1)
- FDA UDI 2a2a3161-b047-4bf0-95d8-e6a0c323dc4e 36 fields · synced May 30, 2026