| Primary Device ID | 10673486002393 |
| NIH Device Record Key | d1da0287-dc7f-4689-8234-7dddbf70e200 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Teco Diagnostics H. pylori Card Test |
| Version Model Number | H730-A |
| Catalog Number | H730-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 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 |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10673486002393 [Primary] |
| LYR | Helicobacter Pylori |
| 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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| 10673486002393 - Teco Diagnostics H. pylori Card Test | 2024-01-24Teco Diagnostics H. pylori Card Test is an immunochromatographic assay for the qualitative determination of IgG antibodies specific to Helicobacter pylori (H. pylori) in human serum. The test is intended for professional use as an aid in the diagnosis of H. pylori infections. |
| 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 |