Identity
- Trade Name
- Lumipulse G Dilution Cartridges FDA UDI
- Generic Name
- Laboratory analyser cuvette IVD, single-use FDA UDI
- Model / Reference
- 230466 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04987270230466 FDA UDI
- 510(k) Number
- K142895 FDA UDI
- GMDN Term
- Laboratory analyser cuvette IVD, single-use FDA UDI
Classification
- 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
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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Height — 4 Centimeter FDA UDIWidth — 18.5 Centimeter FDA UDILength — 11.5 Centimeter FDA UDI
Category: Laboratory analyser cuvette IVD, single-use
Lumipulse G Dilution Cartridges by Fujirebio Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K142895 also covers:
- LUMIPULSE G1200 — FUJIREBIO INC.
- Lumipulse G CA125II Calibrators — FUJIREBIO INC.
- Lumipulse G CA125II Immunoreaction 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 | N/A | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Fujirebio Inc.
Sources (1)
- FDA UDI 287496ef-cbc1-434e-a65b-ac28c5d3405e 36 fields · synced May 30, 2026