FDA UDI
Not in Commercial Distribution
🇺🇸 United States
HELIOS
DI: 42601861205090
·
Model: AUTOMATED IFA SYSTEM
·
Aesku.Systems GmbH & Co. KG
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HELIOS
- Primary DI
- 42601861205090
- Version / Model
- AUTOMATED IFA SYSTEM
- Catalog Number
- IOS-1000
- Company Name
- Aesku.Systems GmbH & Co. KG
- Labeler DUNS
- 341702675
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-27
- Public Version
- 5
- Public Version Date
- 2022-09-16
- Public Version Status
- Update
- Public Device Record Key
- 07d16d70-128f-4240-bed0-00d4f75b20dc
- Distribution End Date
- 2020-03-02
Device Description
Automated system for immunofluorescence processing with an integrated fluorescence microscope and software for routine laboratory use by professional users under controlled environmental conditions.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | Immunology | 866.5100 | 2 |
| PIV | Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use | Immunology | 866.4750 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56705 | Fluorescent immunoassay analyser IVD, laboratory | An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of chemical and/or biological markers in a clinical specimen. The instrument detects fluorescent markers that result from an immunological reaction between the reagents and the specimen, and typically includes an autosampler, reagent dispenser, light source, filter or monochromator, a fluorescent detection system (fluorometer or spectrofluorometer), data processing and/or data display software. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 42601861205090 | GS1 |