| Primary Device ID | B24280LACHUFCSET0 |
| NIH Device Record Key | 93c7f93f-3755-4722-a05b-797fc7da6d59 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Lactoferrin CLIA Re-Calibrator and Control Set |
| Version Model Number | 80-LACHU-FCSET |
| 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 | false |
| Device Combination Product | false |
| Single Use | false |
| 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 |
| 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 | B24280LACHUFCSET0 [Primary] |
| DEG | Lactoferrin, Antigen, Antiserum, Control |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-06-16 |
| Device Publish Date | 2025-06-06 |
| B24280LACHUFCSET0 - Lactoferrin CLIA Re-Calibrator and Control Set | 2025-06-16The Lactoferrin CLIA Re-Calibrator and Control Set is an accessory used in conjunction with the Lactoferrin CLIA Kit (80-LACHU-FC100, 80-LACHU-FC900) by trained laboratory personnel. For In Vitro Diagnostic Use in the United States. |
| B24280LACHUFCSET0 - Lactoferrin CLIA Re-Calibrator and Control Set | 2025-06-16 The Lactoferrin CLIA Re-Calibrator and Control Set is an accessory used in conjunction with the Lactoferrin CLIA Kit (80-LACHU-F |
| B24280PANHUFCSET0 - Pancreatic Elastase CLIA Re-Calibrator and Control Set | 2025-06-16 The Pancreatic Elastase CLIA Re-Calibrator and Control Set is an accessory used in conjunction with the Pancreatic Elastase CLIA |
| B24280LACHUFC1000 - ALPCO Lactoferrin CLIA Kit | 2025-03-11 The Lactoferrin CLIA Kit is a chemiluminescent immunoassay based on the use of specific antibodies against lactoferrin. The Klee |
| 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 |