FDA UDI
In Commercial Distribution
🇺🇸 United States
Identify Health
DI: 10850013035127
·
Model: ID-H5-1
·
MEDICAL DISTRIBUTION GROUP INC
Product Codes
4
GMDN Terms
1
Identifiers
2
Pkg Device Count
25
Basic Information
- Brand Name
- Identify Health
- Primary DI
- 10850013035127
- Version / Model
- ID-H5-1
- Catalog Number
- ID-H5-1
- Company Name
- MEDICAL DISTRIBUTION GROUP INC
- Labeler DUNS
- 064177324
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2020-09-09
- Public Version
- 3
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- 068f5f4b-6473-40ce-ae48-603b4f7d651f
- Distribution End Date
- 2099-09-09
Device Description
Identify Health 5 Panel Drug Test Cup - CLIA Waived COC150/MET500/OPI300/OXY100/THC50 3mm Strip, 25 Tests Per Box
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
- Yes
- 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 |
| DJC | Thin Layer Chromatography, Methamphetamine | Clinical Toxicology | 862.3610 | 2 |
| DJG | Enzyme Immunoassay, Opiates | Clinical Toxicology | 862.3650 | 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 |
|---|---|---|---|---|---|---|
| Unit of Use | 00850013035038 | GS1 | ||||
| Primary | 10850013035127 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K122809 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 30 Degrees Celsius