| Primary Device ID | 10673486001204 |
| NIH Device Record Key | f65fcfe4-27f9-4234-b28e-0cff5d261d82 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Teco Diagnostics Direct Bilirubin TC-Matrix |
| Version Model Number | B538-370TM |
| Catalog Number | B538-370TM |
| 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 | 714-463-1111 |
| hello@tecodiagnostics.com | |
| Phone | 714-463-1111 |
| hello@tecodiagnostics.com | |
| Phone | 714-463-1111 |
| hello@tecodiagnostics.com | |
| Phone | 714-463-1111 |
| hello@tecodiagnostics.com | |
| Phone | 714-463-1111 |
| hello@tecodiagnostics.com | |
| Phone | 714-463-1111 |
| hello@tecodiagnostics.com | |
| Phone | 714-463-1111 |
| hello@tecodiagnostics.com | |
| Phone | 714-463-1111 |
| hello@tecodiagnostics.com | |
| Phone | 714-463-1111 |
| hello@tecodiagnostics.com | |
| Phone | 714-463-1111 |
| hello@tecodiagnostics.com | |
| Phone | 714-463-1111 |
| hello@tecodiagnostics.com | |
| Phone | 714-463-1111 |
| hello@tecodiagnostics.com | |
| Phone | 714-463-1111 |
| hello@tecodiagnostics.com | |
| Phone | 714-463-1111 |
| hello@tecodiagnostics.com | |
| Phone | 714-463-1111 |
| hello@tecodiagnostics.com | |
| Phone | 714-463-1111 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10673486001204 [Primary] |
| CIG | Diazo Colorimetry, Bilirubin |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-07-31 |
| Device Publish Date | 2023-07-21 |
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