| Primary Device ID | B261CANT342200 |
| NIH Device Record Key | c9d9f869-2664-4557-a716-c44e2d0b4ff8 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | CAN-T3-4220 |
| Catalog Number | CAN-T3-4220 |
| Company DUNS | 207718438 |
| Company Name | Diagnostics Biochem Canada Inc |
| 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 | 5192688872 |
| dbc@dbc-labs.com | |
| Phone | 5192688872 |
| dbc@dbc-labs.com |
| 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 |
|---|---|
| HIBCC | B261CANT342200 [Primary] |
| CDP | Radioimmunoassay, Total Triiodothyronine |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-20 |
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| B261CANGH40700 - DBC Growth Hormone (GH) ELISA | 2022-11-23 For the quantitative measurement of Growth Hormone (GH) in human serum by an ELISA (Enzyme-Linked Immunosorbent Assay). For in v |
| B261CANLH40400 - DBC Luteinizing Hormone (LH) ELISA | 2022-11-23 For the quantitative measurement of Luteinizing Hormone (LH) in human serum by an ELISA (Enzyme-Linked Immunosorbent Assay). For |
| B261CANP3050 - DBC Progesterone ELISA | 2022-11-23 For the quantitative measurement of Progesterone in human serum by an ELISA (Enzyme-Linked Immunosorbent Assay). For in vitro di |