| Primary Device ID | 05055845400084 |
| NIH Device Record Key | 1bde5089-8078-4b71-ac31-a1fd040ef599 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 3-Reagent Homocysteine Assay for SYNCHRON UniCel |
| Version Model Number | FHYB100/B08175 |
| Catalog Number | FHYB100/B08175 |
| Company DUNS | 229062427 |
| Company Name | AXIS-SHIELD DIAGNOSTICS LIMITED |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 |
| 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 |
|---|---|
| GS1 | 05055845400084 [Primary] |
| LPS | Urinary Homocystine (Nonquantitative) Test System |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-07-01 |
| 05055845400008 - Axis-Shield Anti-CCP (Cyclic, Citrullinated Peptid | 2018-07-06 The Axis-Shield Anti-CCP test is a semi-quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of |
| 05055845400015 - Axis® Homocysteine EIA | 2018-07-06 The Axis® Homocysteine Enzyme Immunoassay (EIA) is intended for the quantitative determination of total L-homocysteine in human |
| 05055845400022 - Axis-Shield Homocysteine Controls | 2018-07-06 The Axis-Shield Homocysteine Control Kit is intended to be used as an assayed quality control serum when used for the quantitati |
| 05055845400046 - Axis-Shield Active-B12 (Holotranscobalamin) EIA | 2018-07-06 The Axis-Shield Active-B12 (Holotranscobalamin) assay is an enzyme-immunoassay (EIA) for the quantitative determination of holot |
| 05055845400084 - 3-Reagent Homocysteine Assay for SYNCHRON UniCel | 2018-07-06The 3-Reagent Homocysteine Assay for SYNCHRON UniCel DxC System is intended for in vitro quantitative determination of total homocysteine in human ser |
| 05055845400084 - 3-Reagent Homocysteine Assay for SYNCHRON UniCel | 2018-07-06 The 3-Reagent Homocysteine Assay for SYNCHRON UniCel DxC System is intended for in vitro quantitative determination of total hom |
| 05055845400169 - Axis-Shield Liquid Stable (LS) 2-Part Homocysteine | 2018-07-06 The Liquid Stable (LS) 2-Part Homocysteine Reagent is intended for in vitro quantitative determination of total homocysteine in |
| 05055845400176 - Axis-Shield Liquid Stable (LS) 2-Part Homocysteine | 2018-07-06 The Liquid Stable (LS) 2-Part Homocysteine Reagent is intended for in vitro quantitative determination of total homocysteine in |
| 05055845400183 - Axis-Shield Liquid Stable (LS) 2-Part Homocysteine | 2018-07-06 The Liquid Stable (LS) 2-Part Homocysteine Reagent is intended for in vitro quantitative determination of total homocysteine in |