FDA UDI
In Commercial Distribution
🇺🇸 United States
ARK™ Levetiracetam II Control
DI: 00812101030660
·
Model: 5070-0003-00
·
ARK DIAGNOSTICS INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- ARK™ Levetiracetam II Control
- Primary DI
- 00812101030660
- Version / Model
- 5070-0003-00
- Catalog Number
- 5070-0003-00
- Company Name
- ARK DIAGNOSTICS INC
- Labeler DUNS
- 164880598
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-10-24
- Public Version
- 1
- Public Version Date
- 2024-11-01
- Public Version Status
- New
- Public Device Record Key
- 04637c63-31bb-4b98-a6e1-54a6903a5d6f
Device Description
ARK Levetiracetam II Control is intended for use in quality control of the ARK Levetiracetam II Assay.
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 |
|---|---|---|---|---|
| ORI | Levetiracetam Assay | Clinical Toxicology | 862.3350 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55673 | Levetiracetam therapeutic drug monitoring IVD, control | A material which is used to verify the performance of an assay intended to be used for the quantitative measurement and therapeutic monitoring of the central nervous system drug levetiracetam (e.g., Keppra) in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00812101030660 | GS1 |
Customer Contacts
- Phone
- 5102706270
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K232522 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius