FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Immunalysis Corporation
DI: 00840937108642
·
Model: 618UR-0025EX
·
IMMUNALYSIS CORPORATION
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Immunalysis Corporation
- Primary DI
- 00840937108642
- Version / Model
- 618UR-0025EX
- Company Name
- IMMUNALYSIS CORPORATION
- Labeler DUNS
- 080589004
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-13
- Public Version
- 5
- Public Version Date
- 2024-12-19
- Public Version Status
- Update
- Public Device Record Key
- 850d5e7c-3361-499d-84e7-5dd53e46f0fe
- Distribution End Date
- 2016-09-20
Device Description
Immunalysis Corporation SEFRIA Fentanyl Urine Kit 25 Export
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55717 | Opiate/opiate metabolite 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 opiate and/or opiate metabolites 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 | 00840937108642 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius