← Back to catalogue
Lumipulse G Progesterone-N Immunoreaction Cartridges
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Lumipulse G Progesterone-N Immunoreaction Cartridges FDA UDI
- Generic Name
- Progesterone IVD, kit, chemiluminescent immunoassay FDA UDI
- Model / Reference
- 235256 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04987270235256 FDA UDI
- FDA Product Code
- JLS FDA UDI
- GMDN Term
- Progesterone IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1620 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
No
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 Progesterone-N Immunoreaction Cartridges by Fujirebio Inc. — Class I — 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Fujirebio Inc.
Sources (1)
- FDA UDI 1283622a-e290-4911-8ea8-f70d84b97c1b 36 fields · synced Jun 6, 2026