FDA UDI
In Commercial Distribution
🇺🇸 United States
Teco Diagnostics Creatine Kinase-MB (CK-MB) Reagent Set
DI: 10673486001655
·
Model: C614-60
·
TECO DIAGNOSTICS
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Teco Diagnostics Creatine Kinase-MB (CK-MB) Reagent Set
- Primary DI
- 10673486001655
- Version / Model
- C614-60
- Catalog Number
- C614-60
- Company Name
- TECO DIAGNOSTICS
- Labeler DUNS
- 185067774
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-11-17
- Public Version
- 1
- Public Version Date
- 2023-11-27
- Public Version Status
- New
- Public Device Record Key
- 0d70b9e1-23c0-4d98-b6dd-2288dc020e2f
Device Description
Teco Diagnostics Creatine Kinase-MB (CK-MB) Reagent Set is intended to measure the activity of isoenzyme CK-MB 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 |
|---|---|---|---|---|
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | Clinical Chemistry | 862.1215 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 52996 | Creatine kinase myocardial isoenzyme (CKMB) 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 qualitative and/or quantitative detection of creatine kinase myocardial isoenzyme (CKMB) in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10673486001655 | GS1 |
Customer Contacts
- Phone
- 714-463-1111
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K915709 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius