FDA UDI
In Commercial Distribution
🇺🇸 United States
MassTrak™
DI: 00816776020001
·
Model: 186002891
·
WATERS TECHNOLOGIES CORPORATION
Product Codes
3
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MassTrak™
- Primary DI
- 00816776020001
- Version / Model
- 186002891
- Catalog Number
- 186002891
- Company Name
- WATERS TECHNOLOGIES CORPORATION
- Labeler DUNS
- 107186004
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 5
- Public Version Date
- 2021-06-04
- Public Version Status
- Update
- Public Device Record Key
- 14498904-04ed-463b-854c-d2ce3daa3a69
Device Description
Waters® MassTrak™ Immunosuppressants Kit
Device Characteristics
- Single Use
- No
- 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
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MLM | Enzyme Immunoassay, Tracrolimus | Clinical Chemistry | 862.1678 | 2 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | Clinical Chemistry | 862.1660 | 1 |
| JIT | Calibrator, Secondary | Clinical Chemistry | 862.1150 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55444 | Tacrolimus 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 immunosuppressant drug tacrolimus in a clinical specimen. | No | Active |
| 55443 | Tacrolimus 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 immunosuppressant drug tacrolimus in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00816776020001 | GS1 |
Customer Contacts
- Phone
- 1-800-252-4752
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K063868 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – -20 Degrees Celsius