Identity
- Trade Name
- LUMIPULSE G1200 FDA UDI
- Generic Name
- Chemiluminescent immunoassay analyser IVD FDA UDI
- Model / Reference
- 234259 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04987270234259 FDA UDI
- 510(k) Number
- K142895 FDA UDI
- FDA Product Code
- JJE FDA UDI
- GMDN Term
- Chemiluminescent immunoassay analyser IVD 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
Yes
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
No
FDA UDI
Dimensions & Sizes
- Size
- Height — 145 Centimeter FDA UDIWidth — 120 Centimeter FDA UDILength — 80 Centimeter FDA UDI
Category: Chemiluminescent immunoassay analyser IVD
Lumipulse G1200 by Fujirebio Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Chemiluminescent immunoassay analyser IVD.
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- ARCHITECT — Abbott Laboratories, Inc. · Class I
- Atellica IM 1300 Analyzer — Siemens Healthcare Diagnostics · Class I
- Alinity — Abbott Laboratories, Inc. · N
Cleared under the same submission
K142895 also covers:
- Lumipulse G CA125II Calibrators — FUJIREBIO INC.
- Lumipulse G CA125II Immunoreaction Cartridges — FUJIREBIO INC.
- Lumipulse G Dilution Cartridges — FUJIREBIO INC.
- Lumipulse G Specimen Diluent 1 — FUJIREBIO INC.
- Lumipulse G Substrate Solution — FUJIREBIO INC.
- Lumipulse G Wash Solution — FUJIREBIO INC.
- Soda Lime for LUMIPULSE System — FUJIREBIO INC.
- Lumipulse G Wash Solution — Fujirebio Diagnostics, Inc.
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 0762649c-803c-4dd2-87eb-33914a5c51ef 36 fields · synced May 30, 2026