FDA UDI
In Commercial Distribution
🇺🇸 United States
Access Syphilis Calibrators
DI: 15099590763633
·
Model: C80412
·
Beckman Coulter, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Access Syphilis Calibrators
- Primary DI
- 15099590763633
- Version / Model
- C80412
- Catalog Number
- C80412
- Company Name
- Beckman Coulter, Inc.
- Labeler DUNS
- 008254708
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-05-07
- Public Version
- 1
- Public Version Date
- 2025-05-15
- Public Version Status
- New
- Public Device Record Key
- 402ed24d-4f5f-4e2e-8f2c-22792daa26e5
Device Description
The Access Syphilis Calibrators are used to establish calibration (determine the cut-off value) for the Access Syphilis assay. By comparing the light intensity generated by a sample to the cut-off value, the presence or absence of Treponema pallidum antibodies in the sample is determined.
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 |
|---|---|---|---|---|
| 51802 | Treponema pallidum total antibody IVD, calibrator | A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of total antibodies to Treponema pallidum bacteria in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 15099590763633 | GS1 |