| Primary Device ID | 10673486001594 |
| NIH Device Record Key | 2e67f980-261c-464e-97cc-b79c6af1583c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Teco Diagnostics Creatine Kinase (CK-NAC) Liquid Reagent |
| Version Model Number | C519-150 |
| Catalog Number | C519-150 |
| Company DUNS | 185067774 |
| Company Name | TECO DIAGNOSTICS |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 714-463-1111 |
| hello@tecodiagnostics.com | |
| Phone | 714-463-1111 |
| hello@tecodiagnostics.com | |
| Phone | 714-463-1111 |
| hello@tecodiagnostics.com | |
| Phone | 714-463-1111 |
| hello@tecodiagnostics.com | |
| Phone | 714-463-1111 |
| hello@tecodiagnostics.com | |
| Phone | 714-463-1111 |
| hello@tecodiagnostics.com | |
| Phone | 714-463-1111 |
| hello@tecodiagnostics.com | |
| Phone | 714-463-1111 |
| hello@tecodiagnostics.com | |
| Phone | 714-463-1111 |
| hello@tecodiagnostics.com | |
| Phone | 714-463-1111 |
| hello@tecodiagnostics.com | |
| Phone | 714-463-1111 |
| hello@tecodiagnostics.com | |
| Phone | 714-463-1111 |
| hello@tecodiagnostics.com | |
| Phone | 714-463-1111 |
| hello@tecodiagnostics.com | |
| Phone | 714-463-1111 |
| hello@tecodiagnostics.com | |
| Phone | 714-463-1111 |
| hello@tecodiagnostics.com | |
| Phone | 714-463-1111 |
| hello@tecodiagnostics.com | |
| Phone | 714-463-1111 |
| hello@tecodiagnostics.com |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10673486001594 [Primary] |
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-08-04 |
| Device Publish Date | 2023-07-27 |
| 10673486000528 - Teco Diagnostics TC-Thunderbolt Automated Urine Analyzer System | 2024-06-14 Teco Diagnostics TC-Thunderbolt Automated Urine Analyzer System is an in vitro diagnostic device used to automate the urine chem |
| 10673486000498 - Teco Diagnostics Uritek TC-720+ Urine Chemistry Test System | 2024-06-13 Teco Diagnostics Uritek TC-720+ Urine Chemistry Test System consists of the Uritek TC-720+ Urine Analyzer and the Teco Diagnosti |
| 10673486000511 - Teco Diagnostics Uritek TC-201 Urine Chemistry Test System | 2024-06-12 Teco Diagnostics Uritek TC-201 Urine Chemistry Test System consists of the Uritek TC-201 Urine Chemistry Analyzer and the Teco D |
| 10673486002430 - Teco Diagnostics C-Reactive Protein (CRP) Reagent Set | 2024-04-10 Teco Diagnostics C-Reactive Protein (CRP) Reagent Set is used for the qualitative and semi-quantitative measurement of C-reactiv |
| 10673486002447 - Teco Diagnostics Anti-Streptolysin O (ASO) Reagent Set | 2024-04-10 Teco Diagnostics Anti-Streptolysin O (ASO) Reagent Set is for the qualitative and semi-quantitative measurement of antibodies to |
| 10673486002423 - Teco Diagnostics Rheumatoid Factor (RF) Reagent Set | 2024-04-09 Teco Diagnostics Rheumatoid Factor (RF) Reagent Set is for the qualitative and semi-quantitative measurement of RF in human seru |
| 10673486002416 - Teco Diagnostics Urine Reagent Strips (URS-1G) | 2024-04-01 Teco Diagnostics Urine Reagent Strips (URS-1G) are for in vitro semi-quantitative detection of glucose in urine. The URS-1G str |
| 10673486002393 - Teco Diagnostics H. pylori Card Test | 2024-01-24 Teco Diagnostics H. pylori Card Test is an immunochromatographic assay for the qualitative determination of IgG antibodies speci |