FDA UDI
In Commercial Distribution
🇺🇸 United States
Elecsys Troponin T Gen 5
DI: 07613336158951
·
Model: 08469865160
·
Roche Diagnostics GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Elecsys Troponin T Gen 5
- Primary DI
- 07613336158951
- Version / Model
- 08469865160
- Catalog Number
- 08469865160
- Company Name
- Roche Diagnostics GmbH
- Labeler DUNS
- 315028860
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-03-01
- Public Version
- 1
- Public Version Date
- 2022-03-09
- Public Version Status
- New
- Public Device Record Key
- 6cf2136f-b2e1-418b-b3c4-a93788c2c016
Device Description
Troponin T G5 STAT Elecsys cobas e100 V2 (E1G)
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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 |
|---|---|---|---|---|
| MMI | IMMUNOASSAY METHOD, TROPONIN SUBUNIT | Clinical Chemistry | 862.1215 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 54007 | Troponin T 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 qualitative and/or quantitative detection of Troponin T in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07613336158951 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K201441 | 000 |