| Primary Device ID | 10673486002089 | 
| NIH Device Record Key | 957e059f-ad1c-475d-bbf3-c340b1cdd4d2 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Teco Diagnostics Lipase Reagent Set | 
| Version Model Number | L537-100 | 
| Catalog Number | L537-100 | 
| 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 | 7144631111 | 
| hello@tecodiagnostics.com | |
| Phone | 7144631111 | 
| hello@tecodiagnostics.com | |
| Phone | 7144631111 | 
| hello@tecodiagnostics.com | |
| Phone | 7144631111 | 
| hello@tecodiagnostics.com | |
| Phone | 7144631111 | 
| hello@tecodiagnostics.com | |
| Phone | 7144631111 | 
| hello@tecodiagnostics.com | |
| Phone | 7144631111 | 
| hello@tecodiagnostics.com | |
| Phone | 7144631111 | 
| hello@tecodiagnostics.com | |
| Phone | 7144631111 | 
| hello@tecodiagnostics.com | |
| Phone | 7144631111 | 
| hello@tecodiagnostics.com | |
| Phone | 7144631111 | 
| hello@tecodiagnostics.com | |
| Phone | 7144631111 | 
| hello@tecodiagnostics.com | |
| Phone | 7144631111 | 
| hello@tecodiagnostics.com | |
| Phone | 7144631111 | 
| hello@tecodiagnostics.com | |
| Phone | 7144631111 | 
| hello@tecodiagnostics.com | |
| Phone | 7144631111 | 
| hello@tecodiagnostics.com | |
| Phone | 7144631111 | 
| hello@tecodiagnostics.com | 
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius | 
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 10673486002089 [Primary] | 
| CET | Olive Oil Emulsion (Turbidimetric), Lipase | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2023-11-20 | 
| Device Publish Date | 2023-11-10 | 
| 10673486002478 - GLUCOPAD TC-SMART+ Lancets Kit | 2025-06-18 Each GLUCOPAD TC-SMART+ Lancets Kit has 100 pcs per kit. The intended use is for capillary blood sampling on a patient age 6 mo | 
| 10673486013580 - Teco Diagnostics TC Matrix Clinical Chemistry Analyzer | 2025-06-05 Teco Diagnostics TC Matrix Clinical Chemistry Analyzer is a discrete photometric chemistry analyzer for clinical use.The device | 
| 10673486013726 - Teco Diagnostics TC Matrix Clinical Chemistry Analyzer | 2025-06-05 Teco Diagnostics TC Matrix Clinical Chemistry Analyzer is a discrete photometric chemistry analyzer for clinical use. The device | 
| 10673486013894 - Teco Diagnostics TC Matrix Clinical Chemistry Analyzer | 2025-06-05 Teco Diagnostics TC Matrix Clinical Chemistry Analyzer is a discrete photometric chemistry analyzer for clinical use. The device | 
| 10673486013962 - Teco Diagnostics TC Matrix Clinical Chemistry Analyzer | 2025-06-05 Teco Diagnostics TC Matrix Clinical Chemistry Analyzer is a discrete photometric chemistry analyzer for clinical use. The device | 
| 10673486002461 - GLUCOPAD TC-SMART+ Lancets Kit | 2025-05-22 Each GLUCOPAD TC-SMART+ Lancets Kit has 50 pcs per kit. The intended use is for capillary blood sampling on a patient age 6 mont | 
| 10673486000726 - Teco Diagnostics Glucopad Blood Glucose Test Strips | 2024-12-27 Teco Diagnostics Glucopad Blood Glucose Test Strips are to be used for monitoring glucose concentration of fresh capillary whole | 
| 10673486002454 - Teco Diagnostics One-Step Urine/Serum Combo Pregnancy Card Test | 2024-12-27 Teco Diagnostics One-Step Urine/Serum Combo Pregnancy Card Test is a colloidal gold antibody complex based immunoassay designed |