FDA UDI
In Commercial Distribution
🇺🇸 United States
ClearChem Diagnostics Inc. High Sensitivity C-Reactive Protein (hS-CRP)
DI: 00852169008171
·
Model: CRP1320
·
CLEARCHEM DIAGNOSTICS INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ClearChem Diagnostics Inc. High Sensitivity C-Reactive Protein (hS-CRP)
- Primary DI
- 00852169008171
- Version / Model
- CRP1320
- Catalog Number
- CRP1320
- Company Name
- CLEARCHEM DIAGNOSTICS INC.
- Labeler DUNS
- 010655581
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-04-30
- Public Version
- 2
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- d939e8a6-4611-4138-86d4-a12fdb6d7684
Device Description
In Vitro Diagnostics testing kit R1:1X20mL, R2:1X20mL
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- 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 |
|---|---|---|---|---|
| 53707 | C-reactive protein (CRP) IVD, reagent | A substance or reactant intended to be used together with other IVDs to perform a specific function in an assay that is 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 | 00852169008171 | GS1 |
Customer Contacts
- Phone
- +1(714)734-8041
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 40 | Milliliter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Refrigerated