| Primary Device ID | B261CANLH40400 |
| NIH Device Record Key | d97a21d0-93a9-41ab-82e5-8d18b4d54320 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DBC Luteinizing Hormone (LH) ELISA |
| Version Model Number | CAN-LH-4040 |
| Catalog Number | CAN-LH-4040 |
| 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 | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 1-519-681-8731 |
| dbc@dbc-labs.com | |
| Phone | 1-519-681-8731 |
| dbc@dbc-labs.com | |
| Phone | 1-519-681-8731 |
| dbc@dbc-labs.com | |
| Phone | 1-519-681-8731 |
| dbc@dbc-labs.com | |
| Phone | 1-519-681-8731 |
| dbc@dbc-labs.com | |
| Phone | 1-519-681-8731 |
| dbc@dbc-labs.com | |
| Phone | 1-519-681-8731 |
| dbc@dbc-labs.com | |
| Phone | 1-519-681-8731 |
| dbc@dbc-labs.com | |
| Phone | 1-519-681-8731 |
| dbc@dbc-labs.com | |
| Phone | 1-519-681-8731 |
| dbc@dbc-labs.com | |
| Phone | 1-519-681-8731 |
| dbc@dbc-labs.com | |
| Phone | 1-519-681-8731 |
| dbc@dbc-labs.com | |
| Phone | 1-519-681-8731 |
| dbc@dbc-labs.com | |
| Phone | 1-519-681-8731 |
| dbc@dbc-labs.com | |
| Phone | 1-519-681-8731 |
| dbc@dbc-labs.com | |
| Phone | 1-519-681-8731 |
| dbc@dbc-labs.com | |
| Phone | 1-519-681-8731 |
| 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 |
| 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 |
|---|---|
| HIBCC | B261CANLH40400 [Primary] |
| CEP | Radioimmunoassay, Luteinizing Hormone |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-11-23 |
| Device Publish Date | 2022-11-15 |
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| B261CANE4300 - DBC Estradiol ELISA | 2022-11-23 For the quantitative measurement of Estradiol in human serum by an ELISA (Enzyme-Linked Immunosorbent Assay). For in vitro diag |
| B261CANE6400 - DBC Free Estriol ELISA | 2022-11-23 For the quantitative measurement of Free Estriol in human serum by an ELISA (Enzyme-Linked Immunosorbent Assay). For in vitro di |
| B261CANFSH40600 - DBC Follicle Stimulating Hormone (FSH) ELISA | 2022-11-23 For the quantitative measurement of Follicle Stimulating Hormone (FSH) in human serum by an ELISA (Enzyme-Linked Immunosorbent A |
| 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 | 2022-11-23For the quantitative measurement of Luteinizing Hormone (LH) in human serum by an ELISA (Enzyme-Linked Immunosorbent Assay). For in vitro diagnostic use. |
| 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 |
| B261CANP3200 - DBC 17α-Hydroxyprogesterone (17α-OHP) ELISA | 2022-11-23 For the quantitative measurement of 17α-Hydroxyprogesterone in human serum by an ELISA (Enzyme-Linked Immunosorbent Assay). For |