Identity
- Trade Name
- ELITe InGenius® FDA UDI
- Generic Name
- Thermal cycler nucleic acid amplification analyser IVD, laboratory FDA UDI
- Device Name
- The ELITe InGenius® system is an in vitro diagnostic (IVD) platform that performs nucleic acid based tests. The ELITe InGenius system is a fully automated device integrating extraction and purification of nucleic acids from multiple sample types, amplification and detection of the target sequence by real-time Polymerase Chain Reaction (PCR), and result interpretation. ELITe InGenius® is FDA cleared only for use in association with HSV 1&2 ELITe MGB® Assay FDA UDI
- Model / Reference
- INT030-K FDA UDI
- Description
- The ELITe InGenius® system is an in vitro diagnostic (IVD) platform that performs nucleic acid based tests. The ELITe InGenius system is a fully automated device integrating extraction and purification of nucleic acids from multiple sample types, amplification and detection of the target sequence by real-time Polymerase Chain Reaction (PCR), and result interpretation. ELITe InGenius® is FDA cleared only for use in association with HSV 1&2 ELITe MGB® Assay FDA UDI
Identifiers
- Catalog Number
- INT030-K FDA UDI
- Primary DI / UDI-DI
- 03661540900006 FDA UDI
- 510(k) Number
- K180559 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
Yes
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
Yes
FDA UDI
Category: Thermal cycler nucleic acid amplification analyser IVD, laboratory
ELITe InGenius® by Elitechgroup Inc. — 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
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
- Elitechgroup Inc.
Sources (1)
- FDA UDI 34b812de-31c3-4f2f-9bdb-1919dd783892 35 fields · synced May 31, 2026