FDA UDI
In Commercial Distribution
🇺🇸 United States
Syva® Emit® 2000 Siro/Tacro Sample Pretreatment Reagent
DI: 00842768030048
·
Model: 10488260
·
Siemens Healthcare Diagnostics Inc.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
4
Basic Information
- Brand Name
- Syva® Emit® 2000 Siro/Tacro Sample Pretreatment Reagent
- Primary DI
- 00842768030048
- Version / Model
- 10488260
- Catalog Number
- 8S079UL
- Company Name
- Siemens Healthcare Diagnostics Inc.
- Labeler DUNS
- 005088112
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 4
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 5
- Public Version Date
- 2021-11-18
- Public Version Status
- Update
- Public Device Record Key
- c146299c-a327-4025-ac9c-581c78225635
Device Description
Syva® Emit® 2000 Siro/Tacro Sample Pretreatment Reagent
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- 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 |
|---|---|---|---|---|
| NRP | Sirolimus test system | Clinical Toxicology | 862.3840 | 2 |
| MLM | ENZYME IMMUNOASSAY, TRACROLIMUS | Clinical Chemistry | 862.1678 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60457 | Multiple immunosuppressant 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 that is used for the quantitative measurement and therapeutic monitoring of multiple immunosuppressant drugs which may include cyclosporin A (or cyclosporine), tacrolimus, sirolimus and/or everolimus, in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00842768030048 | GS1 | ||||
| Unit of Use | 00630414010526 | GS1 |
Customer Contacts
- Phone
- +1(800)227-8994
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K083487 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 30 Degrees Celsius