FDA UDI
In Commercial Distribution
🇺🇸 United States
CRP Calibrator Set
DI: 00812137012142
·
Model: 5 x 2mL
·
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
Basic Information
- Brand Name
- CRP Calibrator Set
- Primary DI
- 00812137012142
- Version / Model
- 5 x 2mL
- Catalog Number
- 502-154
- Company Name
- CLINICAL DIAGNOSTIC SOLUTIONS, INC.
- Labeler DUNS
- 048144997
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2016-10-12
- Public Version
- 3
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- fd2eb551-ab08-495d-b884-404d0e6b9184
Device Description
The CRP Calibrator Set is intended to be used for the calibration of the CDS CRP Reagents. For in vitro diagnostic use only. The calibrators in this kit contain known quantities of human C-reactive protein. These reagents are to be used as calibrators with the manufacturer’s CRP Reagents.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- Yes
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- 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 |
|---|---|---|---|---|
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | Immunology | 866.5270 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41838 | C-reactive protein (CRP) 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 C-reactive protein (CRP) in a clinical specimen [includes high-sensitivity CRP (hsCRP) types]. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00812137012142 | GS1 | ||||
| Unit of Use | 00812137012432 | GS1 |
Customer Contacts
- Phone
- 8004533328
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius