FDA UDI
In Commercial Distribution
🇺🇸 United States
CardioPhase® hsCRP
DI: 00842768007729
·
Model: 10446090
·
Siemens Healthcare Diagnostics Products GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
3
Basic Information
- Brand Name
- CardioPhase® hsCRP
- Primary DI
- 00842768007729
- Version / Model
- 10446090
- Catalog Number
- OQIY13
- Company Name
- Siemens Healthcare Diagnostics Products GmbH
- Labeler DUNS
- 388240673
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 3
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 8
- Public Version Date
- 2023-12-08
- Public Version Status
- Update
- Public Device Record Key
- 482837d8-eead-4b7d-afdb-3e0e7740feec
Device Description
Quantitative determination of C-reactive protein (CRP) in human serum and plasma on Siemens Systems
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- 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 |
|---|---|---|---|---|
| NQD | CARDIAC C-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROL | Immunology | 866.5270 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 53705 | C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of C-reactive protein (CRP) in a clinical specimen, using a nephelometry/turbidimetry method [includes high-sensitivity CRP (hsCRP) types]. CRP is a marker associated with bacterial infection, inflammatory conditions, and cardiovascular disease. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00842768007729 | GS1 | ||||
| Unit of Use | 00842768019012 | GS1 |
Customer Contacts
- Phone
- +1(800)664-3822
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius