| Primary Device ID | 05055845400596 |
| NIH Device Record Key | 3ec3069f-5035-4b5f-aac5-600d6bf90717 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Alere NT-proBNP for Alinity Reagent Kit (200 Tests) |
| Version Model Number | 04S7921 |
| Catalog Number | 04S7921 |
| 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 | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 877-441-7440 |
| USProductsupport@abbott.com | |
| Phone | 877-441-7440 |
| USProductsupport@abbott.com | |
| Phone | 877-441-7440 |
| USProductsupport@abbott.com | |
| Phone | 877-441-7440 |
| USProductsupport@abbott.com | |
| Phone | 877-441-7440 |
| USProductsupport@abbott.com | |
| Phone | 877-441-7440 |
| USProductsupport@abbott.com | |
| Phone | 877-441-7440 |
| USProductsupport@abbott.com | |
| Phone | 877-441-7440 |
| USProductsupport@abbott.com | |
| Phone | 877-441-7440 |
| USProductsupport@abbott.com | |
| Phone | 877-441-7440 |
| USProductsupport@abbott.com | |
| Phone | 877-441-7440 |
| USProductsupport@abbott.com | |
| Phone | 877-441-7440 |
| USProductsupport@abbott.com | |
| Phone | 877-441-7440 |
| USProductsupport@abbott.com | |
| Phone | 877-441-7440 |
| USProductsupport@abbott.com | |
| Phone | 877-441-7440 |
| USProductsupport@abbott.com | |
| Phone | 877-441-7440 |
| USProductsupport@abbott.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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05055845400596 [Primary] |
| NBC | Test, Natriuretic Peptide |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-03-06 |
| Device Publish Date | 2025-02-26 |
| 05055845400527 - Alere NT-proBNP for Alinity Control Kit | 2025-03-07 The Alere NT-proBNP for Alinity i Controls are for the estimation of test precision and the detection of systematic analytical d |
| 05055845400534 - Alere NT-proBNP for Alinity Calibrator Kit | 2025-03-07 The Alere NT-proBNP for Alinity i Calibrators are for the calibration of the Alinity i analyzer when used for the quantitative d |
| 05055845400596 - Alere NT-proBNP for Alinity Reagent Kit (200 Tests) | 2025-03-06The Alere NT-proBNP for Alinity i assay is a chemiluminescent microparticle immunoassay (CMIA) used for the in vitro quantitative determination of N-terminal pro B-type natriuretic peptide (NT-proBNP) in human serum and plasma on the Alinity i system. In the emergency department, measurements of NT-proBNP are used as an aid in the diagnosis of heart failure (HF) in patients with clinical suspicion of new onset or worsening HF. |
| 05055845400596 - Alere NT-proBNP for Alinity Reagent Kit (200 Tests) | 2025-03-06 The Alere NT-proBNP for Alinity i assay is a chemiluminescent microparticle immunoassay (CMIA) used for the in vitro quantitativ |
| 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 | 2018-07-06 The 3-Reagent Homocysteine Assay for SYNCHRON UniCel DxC System is intended for in vitro quantitative determination of total hom |