FDA UDI
In Commercial Distribution
🇺🇸 United States
Healgen
DI: 00810173656009
·
Model: HDOA-124
·
Healgen Scientific Limited Liability Company
Product Codes
2
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Healgen
- Primary DI
- 00810173656009
- Version / Model
- HDOA-124
- Company Name
- Healgen Scientific Limited Liability Company
- Labeler DUNS
- 031802328
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-03-11
- Public Version
- 1
- Public Version Date
- 2026-03-19
- Public Version Status
- New
- Public Device Record Key
- 7d142c99-db84-4d6e-a818-8c29ddc57fcf
Device Description
K240686 2 Panel DOA Test Dip card: COC300, THC50
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | Clinical Toxicology | 862.3250 | 2 |
| LDJ | Enzyme Immunoassay, Cannabinoids | Clinical Toxicology | 862.3870 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46994 | Multiple drugs of abuse IVD, kit, rapid ICT, clinical | A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of multiple drugs of abuse in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10810173656006 | GS1 | inner pack | 25 | In Commercial Distribution | |
| Primary | 00810173656009 | GS1 | ||||
| Package | 20810173656003 | GS1 | case | 20 | In Commercial Distribution |
Customer Contacts
- Phone
- 7137338088
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 30 Degrees Celsius