| Primary Device ID | B24220PROHUE010 |
| NIH Device Record Key | b367c64b-376a-41c1-bfca-3af422341b52 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Prolactin ELISA |
| Version Model Number | 20-PROHU-E01 |
| Catalog Number | 20-PROHU-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 | 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 | false |
| OTC Over-The-Counter | false |
| Phone | 800-592-5726 |
| cs@alpco.com | |
| Phone | 800-592-5726 |
| cs@alpco.com | |
| Phone | 800-592-5726 |
| cs@alpco.com | |
| Phone | 800-592-5726 |
| cs@alpco.com | |
| Phone | 800-592-5726 |
| cs@alpco.com | |
| Phone | 800-592-5726 |
| cs@alpco.com | |
| Phone | 800-592-5726 |
| cs@alpco.com | |
| Phone | 800-592-5726 |
| cs@alpco.com | |
| Phone | 800-592-5726 |
| cs@alpco.com | |
| Phone | 800-592-5726 |
| cs@alpco.com | |
| Phone | 800-592-5726 |
| cs@alpco.com | |
| Phone | 800-592-5726 |
| cs@alpco.com | |
| Phone | 800-592-5726 |
| cs@alpco.com | |
| Phone | 800-592-5726 |
| cs@alpco.com | |
| Phone | 800-592-5726 |
| cs@alpco.com | |
| Phone | 800-592-5726 |
| cs@alpco.com | |
| Phone | 800-592-5726 |
| cs@alpco.com | |
| Phone | 800-592-5726 |
| cs@alpco.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 |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B24220PROHUE010 [Primary] |
| CFT | Radioimmunoassay, Prolactin (Lactogen) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-03-02 |
| Device Publish Date | 2023-02-22 |
| 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 |
| B24220EDLHUUE010 - Ultrasensitive Estradiol ELISA | 2023-06-15 The Ultrasensitive Estradiol ELISA is an enzyme immunoassay for the quantitative measurement of estradiol in serum or plasma (ED |
| B24211PRNHUE010 - Pregnenolone ELISA | 2023-06-02 Intended for the direct quantitative determination of Pregnenolone by enzyme immunoassay using human serum. For in vitro diagnos |
| B24211FTEHUE010 - Free Testosterone ELISA | 2023-05-03 For the direct quantitative determination of Free Testosterone by an enzyme immunoassay in human serum. For in vitro diagnostic |
| B24220PROHUE010 - Prolactin ELISA | 2023-03-02The Prolactin ELISA is an enzyme immunoassay for the quantitative determination of Prolactin in human serum. For in vitro diagnostic use in the United States of America. For research use only in other territories. |
| B24220PROHUE010 - Prolactin ELISA | 2023-03-02 The Prolactin ELISA is an enzyme immunoassay for the quantitative determination of Prolactin in human serum. For in vitro diagno |