Primary Device ID | 10673486000528 |
NIH Device Record Key | 90843c4c-7745-49b9-84ff-98a03458e0a6 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Teco Diagnostics TC-Thunderbolt Automated Urine Analyzer System |
Version Model Number | TC-Thunderbolt |
Catalog Number | TC-Thunderbolt |
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 | false |
Device Combination Product | true |
Single Use | false |
Lot Batch | true |
Serial Number | true |
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 |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Device Issuing Agency | Device ID |
---|---|
GS1 | 10673486000528 [Primary] |
JIR | Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-06-14 |
Device Publish Date | 2024-06-06 |
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 |