FDA UDI
In Commercial Distribution
🇺🇸 United States
VITROS
DI: 10758750032891
·
Model: 6900040
·
ORTHO CLINICAL DIAGNOSTICS
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- VITROS
- Primary DI
- 10758750032891
- Version / Model
- 6900040
- Catalog Number
- 6900040
- Company Name
- ORTHO CLINICAL DIAGNOSTICS
- Labeler DUNS
- 215865786
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-12-30
- Public Version
- 1
- Public Version Date
- 2026-01-07
- Public Version Status
- New
- Public Device Record Key
- 22dcd355-a050-44c4-88cd-22866ed0c057
Device Description
VITROS Immunodiagnostic Products hs Troponin I Low Control
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | Clinical Chemistry | 862.1660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 54012 | Troponin I IVD, control | A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of troponin I in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10758750032891 | GS1 | ||||
| Package | 20758750032898 | GS1 | Case | 30 | In Commercial Distribution |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius