FDA UDI
In Commercial Distribution
🇺🇸 United States
ARK™ Methotrexate Control
DI: 00858724003391
·
Model: 5026-0003-03
·
ARK DIAGNOSTICS INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ARK™ Methotrexate Control
- Primary DI
- 00858724003391
- Version / Model
- 5026-0003-03
- Catalog Number
- 5026-0003-03
- Company Name
- ARK DIAGNOSTICS INC
- Labeler DUNS
- 164880598
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-03-01
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 553cbce3-4843-4911-a48d-6457da999711
Device Description
The ARK™ Methotrexate Control consists of a three-level set used for quality control of the assay (tri-level calibration range set). The controls consist of a synthetic protein matrix and the levels are 0.07 umol/L, 0.40 umol/L and 0.80umol/L.
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 |
|---|---|---|---|---|
| LAS | Drug Specific Control Materials | Clinical Toxicology | 862.3280 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38535 | Methotrexate 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 antineoplastic drug methotrexate in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00858724003391 | GS1 |
Customer Contacts
- Phone
- 5102706270
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K111904 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius