FDA UDI
In Commercial Distribution
🇺🇸 United States
VITROS
DI: 10758750035069
·
Model: 6177334
·
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
- 10758750035069
- Version / Model
- 6177334
- Catalog Number
- 6177334
- Company Name
- ORTHO CLINICAL DIAGNOSTICS
- Labeler DUNS
- 215865786
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-09-18
- Public Version
- 2
- Public Version Date
- 2025-02-19
- Public Version Status
- Update
- Public Device Record Key
- 56c3c497-d0be-44f9-922f-c062964954a1
Device Description
VITROS Immunodiagnostic Products Syphilis Calibrator
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 |
|---|---|---|---|---|
| JIT | Calibrator, secondary | Clinical Chemistry | 862.1150 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59863 | Treponema pallidum total antibody IVD, kit, chemiluminescent immunoassay | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total antibodies to Treponema pallidum in a clinical specimen using a chemiluminescent immunoassay method. The assay is designed to detect infection with Treponema pallidum, the bacteria associated with syphilis. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20758750035066 | GS1 | Case | 30 | In Commercial Distribution | |
| Primary | 10758750035069 | GS1 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Opened calibrators may be stored frozen, with no more than 5 freeze-thaw cycles
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius