Lumipulse G Substrate Solution

FDA UDI

Class I (US FDA UDI)

by Fujirebio Inc.

Identity

Trade Name: Lumipulse G Substrate Solution FDA UDI
Generic Name: Chemiluminescent substrate reagent IVD FDA UDI
Model / Reference: 231197 FDA UDI

Identifiers

Primary DI / UDI-DI: 04987270231197 FDA UDI
510(k) Number: K142895 FDA UDI
FDA Product Code: JJE FDA UDI
GMDN Term: Chemiluminescent substrate reagent 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Total Volume — 600 Milliliter FDA UDI

Category: Chemiluminescent substrate reagent IVD

Lumipulse G Substrate Solution by Fujirebio Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K142895 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: Fujirebio Inc.

Sources (1)

FDA UDI 29d4cbf0-45e1-4175-be6d-8d1999efd1bc 36 fields · synced Jun 8, 2026