FDA UDI
In Commercial Distribution
🇺🇸 United States
Carolina Liquid Chemistries Corp. Fentanyl Enzyme Immunoassay (FENT) DT428
DI: 00817302022292
·
Model: DT428
·
CAROLINA LIQUID CHEMISTRIES CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Carolina Liquid Chemistries Corp. Fentanyl Enzyme Immunoassay (FENT) DT428
- Primary DI
- 00817302022292
- Version / Model
- DT428
- Catalog Number
- DT428
- Company Name
- CAROLINA LIQUID CHEMISTRIES CORPORATION
- Labeler DUNS
- 962385787
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-04-30
- Public Version
- 1
- Public Version Date
- 2020-05-08
- Public Version Status
- New
- Public Device Record Key
- fc318dd7-acb8-4f31-a6ce-52f85514ac27
Device Description
Fentanyl Enzyme Immunoassay
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| DJG | Enzyme immunoassay, opiates | Clinical Toxicology | 862.3650 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63018 | Fentanyl IVD, kit, enzyme immunoassay (EIA) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of fentanyl in a clinical specimen, using an enzyme immunoassay (EIA) method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00817302022292 | GS1 |
Customer Contacts
- Phone
- +1(800)471-7272
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Kit contains 2 R1 bottles and 2 R2 bottles | ||
| Total Volume | 30 | Milliliter | |
| Total Volume | 10 | Milliliter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Reagent is stable when stored unopened at 2-8° C until expiration date.
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius