FDA UDI
In Commercial Distribution
🇺🇸 United States
Teco Diagnostics C-Reactive Protein (CRP) Reagent Set
DI: 10673486002430
·
Model: CRP-100
·
TECO DIAGNOSTICS
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Teco Diagnostics C-Reactive Protein (CRP) Reagent Set
- Primary DI
- 10673486002430
- Version / Model
- CRP-100
- Catalog Number
- CRP-100
- Company Name
- TECO DIAGNOSTICS
- Labeler DUNS
- 185067774
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-04-02
- Public Version
- 1
- Public Version Date
- 2024-04-10
- Public Version Status
- New
- Public Device Record Key
- b57c327e-bfe6-4e91-aee6-46bd5b8226ea
Device Description
Teco Diagnostics C-Reactive Protein (CRP) Reagent Set is used for the qualitative and semi-quantitative measurement of C-reactive protein (CRP) in human serum.
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 |
|---|---|---|---|---|
| 63234 | C-reactive protein (CRP) IVD, kit, rapid agglutination, clinical | A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of C-reactive protein (CRP) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using a rapid agglutination method. CRP is a marker associated with bacterial infection and inflammatory conditions. This is a rapid test commonly used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10673486002430 | GS1 |
Customer Contacts
- Phone
- 7144631111
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K962019 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius