Identity
- Trade Name
- Lamp, Halogen RC, IVD FDA UDI
- Generic Name
- Thermal cycler nucleic acid amplification analyser IVD, laboratory FDA UDI
- Device Name
- LAMP,HALOGEN RC, IVD FDA UDI
- Model / Reference
- 4480914 FDA UDI
- Description
- LAMP,HALOGEN RC, IVD FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10190302000734 FDA UDI
- 510(k) Number
- K123955 FDA UDI
- FDA Product Code
- OOI FDA UDI
- GMDN Term
- Thermal cycler nucleic acid amplification analyser IVD, laboratory FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.2570 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
Category: Thermal cycler nucleic acid amplification analyser IVD, laboratory
Lamp, Halogen RC, IVD by Life Technologies Holdings Pte. Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Thermal cycler nucleic acid amplification analyser IVD, laboratory.
- FilmArray® 2.0 Instrument NGDS Configuration — BioFire Defense, LLC · Class II
- m2000 — Abbott Molecular · Class II
- FilmArray® 2.0 Instrument NGDS Configuration — BioFire Defense, LLC · Class II
- QuantStudio™ 7 Pro Dx Software, V3.0.0 — LIFE TECHNOLOGIES LIMITED · Class II
- COBAS®TaqMan® 48 Analyzer — Roche Molecular Systems, Inc. · Class I
- FilmArray® Torch Module — BioFire Diagnostics, LLC · Class II
- QLoci — LIFEOS GENOMICS CORPORATION · Class II
- GeneXpert Dx System — CEPHEID · Class II
Cleared under the same submission
K123955 also covers:
- Fast 96-Well Block — LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
- Fast 96-Well Heater Cover — LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
- QuantStudio(TM) Dx Software Version 1.0.4 — LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
- QuantStudioTM Dx Real-Time PCR Instrument — LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
- QuantStudio Dx Software V1.0.3, Kit — LIFE TECHNOLOGIES LIMITED
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
- Life Technologies Holdings Pte. Ltd.
Sources (1)
- FDA UDI fb81bf11-eb6a-4bab-bd2f-76136b7b036f 34 fields · synced May 30, 2026