Healgen
- Primary DI
- 10850076346017
- Brand
- Healgen
- Company
- HEALGEN LIFE SCIENCE, LLC
- Model
- OG-H180
- Device description
- The Healgen Immunofluorescence analyzer OG-H180 is a portable fluorescence instrument for in vitro diagnostic use only. It is designed to perform in vitro diagnostic tests on clinical specimens including drug urine test.
- Published
- 2026-02-06
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| KHO | Fluorometer, For Clinical Use |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| KHO | Fluorometer, For Clinical Use | Clinical Chemistry | 1 |
Premarket Details
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|
| K251972 | 000 | Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180) | Healgen Scientific,, LLC | 2025-08-15 | DJG |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 10850076346017 | Package | GS1 | 1 | In Commercial Distribution |
| 00850076346010 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 10850076346017 | 10850076346017 | | |
| 00850076346010 | 00850076346010 | 850076346010 | 0850076346010 |
GMDN Terms
| Term | Definition |
|---|
| Fluorescent immunoassay analyser IVD, point-of-care | A portable, electrically-powered instrument typically used to scan an immunoassay reagent vehicle (e.g., test strip, cassette, or card) after exposure to a clinical specimen, to provide a quantitative, semi-quantitative, and/or qualitative in vitro determination of chemical substances and/or biological markers in a clinical specimen. The instrument detects fluorescent markers that result from the immunological reaction between the reagents and the specimen. It is mostly used for rapid in vitro diagnostic measurements at the point-of-care and in the laboratory. |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Storage Environment Temperature | 2 Degrees Celsius | 30 Degrees Celsius | |
Regulatory Flags
- DUNS number
- 098183434
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- true
- Manufacturing date on label
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| 00850076346027 | Healgen | FBFEN-102G | | 2026-02-06 |
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