FDA UDI
In Commercial Distribution
🇺🇸 United States
Teco Diagnostics Carbon Dioxide (CO2) Reagent Set
DI: 10673486001624
·
Model: C525-60
·
TECO DIAGNOSTICS
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Teco Diagnostics Carbon Dioxide (CO2) Reagent Set
- Primary DI
- 10673486001624
- Version / Model
- C525-60
- Catalog Number
- C525-60
- Company Name
- TECO DIAGNOSTICS
- Labeler DUNS
- 185067774
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-25
- Public Version
- 1
- Public Version Date
- 2023-08-02
- Public Version Status
- New
- Public Device Record Key
- 63a9aa01-2fc4-4271-8657-4eb4bfe1dd11
Device Description
Teco Diagnostics Carbon Dioxide (CO2) Reagent Set is used for manual or automated quantitative determination of carbon dioxide content in human plasma or serum at 340 nm.
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 |
|---|---|---|---|---|
| KHS | Enzymatic, Carbon-Dioxide | Clinical Chemistry | 862.1160 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60774 | Carbon dioxide (CO2) IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of bicarbonate (HCO3-) ions [as a measure of carbon dioxide (CO2) concentration] in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10673486001624 | GS1 |
Customer Contacts
- Phone
- 714-463-1111
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K942735 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius