FDA UDI
In Commercial Distribution
🇺🇸 United States
POINTE SCIENTIFIC CRP Calibrator Set (5, 20, 40, 160, 320 mg/L)
DI: 00811727011046
·
Model: C7568-CAL
·
POINTE SCIENTIFIC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- POINTE SCIENTIFIC CRP Calibrator Set (5, 20, 40, 160, 320 mg/L)
- Primary DI
- 00811727011046
- Version / Model
- C7568-CAL
- Catalog Number
- C7568-CAL
- Company Name
- POINTE SCIENTIFIC, INC.
- Labeler DUNS
- 045623154
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-31
- Public Version
- 4
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- bdec0579-8fc4-4581-a61a-7eb834511795
Device Description
The Pointe Scientific CRP (HS) Wide Range Multi-Calibrator Set is intended to be used for the calibration of the manufacturer’s CRP (High Sensitivity) Wide Range immunoturbidimetric assay. For in vitro diagnostic use only.
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
- 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 | 00811727011046 | GS1 |
Customer Contacts
- Phone
- 800-445-9853
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K030545 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius