| Primary Device ID | 00884999050587 |
| NIH Device Record Key | 3237a363-95d5-45aa-9db4-6495aac09a89 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Alinity m |
| Version Model Number | 09N61-085 |
| Catalog Number | 09N61-085 |
| Company DUNS | 878263359 |
| Company Name | ABBOTT MOLECULAR INC. |
| 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 | true |
| 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 | true |
| OTC Over-The-Counter | false |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00884999050587 [Primary] |
| PGI | Herpes virus (VZV, HSV1, HSV2), DNA detection assay for cutaneous and mucocutaneous lesion samples |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-08-05 |
| Device Publish Date | 2024-07-26 |
| 00884999048171 | Alinity m IRU Waste Container |
| 00884999048096 | Alinity m Sample Rack Holder |
| 20884999047864 | Alinity m Integrated Reaction Unit (IRU) |
| 20884999047857 | Alinity m Pipette Tips, 1000uL |
| 20884999047840 | Allinity m Pipette Tips, 50uL |
| 00884999047501 | Alinity m CO-RE Tip Sleeve |
| 00884999047488 | Alinity m Pipette Tip Adapters |
| 00884999047464 | Alinity m Universal Sample Rack |
| 00884999047457 | Alinity m Handheld Barcode Scanner |
| 00884999047440 | Alinity m Assay Tray Carrier |
| 00884999047433 | Alinity m Waste Bottle |
| 00884999047426 | Alinity m Waste Box |
| 00884999048652 | Alinity m HCV Application Specification File |
| 00884999047839 | Alinity m HCV CTRL Kit |
| 00884999047822 | Alinity m HCV CAL Kit |
| 00884999047761 | Alinity m HCV AMP Kit |
| 00884999049222 | Alinity m SARS-CoV-2 AMP Kit |
| 00884999049208 | Alinity m SARS-CoV-2 CTRL Kit |
| 00884999049185 | Alinity m SARS-CoV-2 Application Specification File |
| 20884999047901 | Alinity m Diluent Solution Kit |
| 00884999047716 | Alinity m Vapor Barrier Solution |
| 00884999048034 | Alinity m System |
| 00884999047730 | 08N45-095 |
| 00884999048638 | Alinity m HIV-1 Application Specification File |
| 00884999047785 | 08N45-085 |
| 00884999047778 | 08N45-075 |
| 00884999048645 | Alinity m HBV Application Specification File |
| 00884999047815 | Alinity m HBV CTRL Kit |
| 00884999047808 | Alinity m HBV CAL Kit |
| 00884999047754 | Alinity m HBV AMP Kit |
| 00884999049413 | Alinity m Resp-4-Plex Application Specification File |
| 00884999049406 | Alinity m Resp-4-Plex CTRL Kit |
| 00884999049390 | Alinity m Resp-4-Plex AMP Kit |
| 00884999050020 | 1.00 |
| 00884999050136 | Alinity m SARS COV-2 Application Specification File |
| 00884999050211 | Alinity m SARS-CoV-2 Application Specification |
| 00884999047877 | Alinity m Lysis Solution |
| 00884999047679 | Alinity m Sample Prep Kit 2 |
| 00884999049314 | Alinity m Bottle for Ethanol Use |
| 30884999050410 | 09N19-012 |
| 00884999047693 | Alinity m Ethanol Solution |
| 00884999047686 | Alinity m Sample Prep Kit 1 |
| 00884999050280 | Abbott Bulk Universal Collection Kit |
| 00884999049956 | Alinity m CMV Application Specification File |
| 00884999049611 | Alinity m CMV AMP Kit |
| 00884999049604 | Alinity m CMV CTRL Kit |
| 00884999049598 | Alinity m CMV CAL Kit |
| 00884999048669 | Alinity m STI Application Specification File |
| 00884999048607 | Alinity m STI CTRL Kit |
| 00884999048591 | Alinity m STI AMP Kit |