FDA UDI
In Commercial Distribution
🇺🇸 United States
ARK™ Methotrexate Calibrator
DI: 00858724003117
·
Model: 5026-0002-00
·
ARK DIAGNOSTICS INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ARK™ Methotrexate Calibrator
- Primary DI
- 00858724003117
- Version / Model
- 5026-0002-00
- Catalog Number
- 5026-0002-00
- 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
- e62acc79-9c53-445c-bf59-53135677f843
Device Description
The ARK™ Methotrexate Calibrator consists of a six-level set to calibrate the ARK™ Methotrexate Assay. The calibrators consist of a synthetic protein matrix and the levels are 0.00 umol/L, 0.05 umol/L, 0.15 umol/L, 0.25 umol/L, 0.50 umol/L and 1.2 umol/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 |
|---|---|---|---|---|
| DLJ | Calibrators, Drug Specific | Clinical Toxicology | 862.3200 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55322 | Methotrexate therapeutic drug monitoring IVD, calibrator | A material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement and therapeutic monitoring of the anti-neoplastic drug methotrexate in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00858724003117 | 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