| Primary Device ID | B24211HGHHUE010 |
| NIH Device Record Key | 1a758c8c-67d3-45f3-a6d0-236ff2a7420f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Human Growth Hormone ELISA |
| Version Model Number | 11-HGHHU-E01 |
| Catalog Number | 11-HGHHU-E01 |
| Company DUNS | 784143778 |
| Company Name | AMERICAN LABORATORY PRODUCTS COMPANY, LTD. |
| 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 |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B24211HGHHUE010 [Primary] |
| CFL | Radioimmunoassay, Human Growth 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 | 2025-01-28 |
| Device Publish Date | 2025-01-20 |
| B24211HGHHUE010 - Human Growth Hormone ELISA | 2025-01-28The Glucagon ELISA is for the quantitative measurement of Growth Hormone (GH) in human serum by an ELISA (Enzyme-Linked Immunosorbent Assay). For in vitro diagnostic use. |
| B24211HGHHUE010 - Human Growth Hormone ELISA | 2025-01-28 The Glucagon ELISA is for the quantitative measurement of Growth Hormone (GH) in human serum by an ELISA (Enzyme-Linked Immunoso |
| B24211GLUHUE010 - Glucagon ELISA | 2024-10-31 The Glucagon ELISA is a quantitative Enzyme-Linked Immunosorbent Assay for the determination of Glucagon in human EDTA plasma sa |
| B24280PANHUFC1000 - ALPCO Pancreatic Elastase CLIA | 2024-08-02 The Pancreatic Elastase CLIA kit is a chemiluminescent immunoassay (CLIA) intended for use by trained laboratory personnel for t |
| B24220TT3HUE011 - Total Triiodothyronine (Total T3) ELISA | 2024-07-30 The Total Triiodothyronine (Total T3) ELISA Kit is intended for the quantitative determination of total triiodothyronine (T3) co |
| B24280CALPHUIT2000 - ALPCO Calprotectin Immunoturbidimetric Assay | 2023-08-28 The ALPCO Calprotectin Immunoturbidimetric Assay is an in-vitro diagnostic assay intended for the quantitative measurement of hu |
| B24280CALPHUITCAL0 - Calprotectin Immunoturbidimetric Assay - Calibrators | 2023-08-28 The Calprotectin Immunoturbidimetric Assay - Calibrators is an accessory used in conjunction with the Calprotectin Immunoturbidi |
| B24280CALPHUITCON0 - ALPCO Calprotectin Immunoturbidimetric Assay | 2023-08-28 The Calprotectin Immunoturbidimetric Assay - Controls is an accessory used in conjunction with the Calprotectin Immunoturbidimet |
| B24280CALPHUIT100 - ALPCO Calprotectin Immunoturbidimetric Assay | 2023-06-19 The ALPCO Calprotectin Immunoturbidimetric Assay is an in-vitro diagnostic assay intended for the quantitative measurement of hu |