FDA UDI
In Commercial Distribution
🇺🇸 United States
ARK™ Oxcarbazepine Metabolite Assay
DI: 00858724003308
·
Model: 5032-0001-00
·
ARK DIAGNOSTICS INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ARK™ Oxcarbazepine Metabolite Assay
- Primary DI
- 00858724003308
- Version / Model
- 5032-0001-00
- Catalog Number
- 5032-0001-00
- Company Name
- ARK DIAGNOSTICS INC
- Labeler DUNS
- 164880598
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 9ff1dd7a-f5e3-4e68-b191-2514397625f6
Device Description
The ARK™ Oxcarbazepine Metabolite Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of Oxcarbazepine Metabolite in human serum on automated clinical chemistry analyzers. The measurements obtained are used in monitoring levels of Oxcarbazepine Metabolite to help ensure appropriate therapy.
Device Characteristics
- Single Use
- Yes
- 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 |
|---|---|---|---|---|
| POX | Enzyme Immunoassay, Oxcarbazepine Metabolite | Clinical Toxicology | 862.3645 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61982 | Multiple anticonvulsant therapeutic drug monitoring IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay intended to be used for the quantitative measurement and therapeutic monitoring of multiple anticonvulsant drugs, also known as antiepileptic drugs which may include carbamazepine, lamotrigine, phenytoin, and primidone, in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00858724003308 | GS1 |
Customer Contacts
- Phone
- 5102706270
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K153596 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius