| Primary Device ID | 10673486001006 |
| NIH Device Record Key | 717d06bc-29e3-4125-89fe-78f59a54d009 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Teco Diagnostics Urine Porphobilinogen (PBG) Test Kit |
| Version Model Number | URS-PBG-1 |
| Catalog Number | URS-PBG-1 |
| Company DUNS | 185067774 |
| Company Name | TECO DIAGNOSTICS |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| 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 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 | 10673486001006 [Primary] |
| JNF | Ion-Exchange Resin, Ehrlich'S Reagent, Porphobilinogen |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-12-15 |
| Device Publish Date | 2023-12-07 |
| 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 |
| 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 |