| Primary Device ID | 10673486002409 |
| NIH Device Record Key | 3bd8092d-06b8-4313-a8f8-5625879bc112 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Teco Diagnostics One-Step Urine/Serum Combo Pregnancy Card Test |
| Version Model Number | P596-A |
| Catalog Number | P596-A |
| 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 | 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 | |
| Phone | 7144631111 |
| hello@tecodiagnostics.com |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10673486002409 [Primary] |
| JHI | Visual, Pregnancy Hcg, Prescription Use |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-01-24 |
| Device Publish Date | 2024-01-16 |
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| 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 |
| 10673486002409 - Teco Diagnostics One-Step Urine/Serum Combo Pregnancy Card Test | 2024-01-24Teco Diagnostics One-Step Urine/Serum Combo Pregnancy Card Test is a colloidal gold antibody complex based immunoassay designed for the qualitative determination of human chorionic gonadotropin (hCG) in serum or urine. This test is for professional use in obtaining a visual qualitative result for the early detection of pregnancy. |
| 10673486002409 - Teco Diagnostics One-Step Urine/Serum Combo Pregnancy Card Test | 2024-01-24 Teco Diagnostics One-Step Urine/Serum Combo Pregnancy Card Test is a colloidal gold antibody complex based immunoassay designed |
| 10673486001006 - Teco Diagnostics Urine Porphobilinogen (PBG) Test Kit | 2023-12-15 Teco Diagnostics Urine Porphobilinogen (PBG) Test Kit is intended for the in vitro qualitative determination of porphobilinogen |
| 10673486001785 - Teco Diagnostics Glucose (Oxidase) Liquid Reagent Set | 2023-12-08 Teco Diagnostics Glucose (Oxidase) Liquid Reagent Set is used for the quantitative determination of total glucose in serum. |