| Primary Device ID | 08056771602709 |
| NIH Device Record Key | defc47f6-8c51-4afd-887f-cd43ecc6b3ef |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LIAISON Lyme Total Antibody Plus |
| Version Model Number | 318330 |
| Company DUNS | 033429783 |
| Company Name | Diasorin 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 | 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 | true |
| OTC Over-The-Counter | false |
| Phone | 651-439-9710 |
| info@diasorin.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08056771602709 [Primary] |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-02-11 |
| Device Publish Date | 2020-02-03 |
| 08056771600811 - ANAFLUOR™ | 2026-02-09 |
| 08056771600828 - ANAFLUOR™ | 2026-02-09 |
| 08056771600835 - ANAFLUOR ™ | 2026-02-09 |
| 08056771600842 - ANAFLUOR™ | 2026-02-09 |
| 08056771600859 - ANAFAST™ ANA Fluorescent Test System 240 Wells | 2026-02-09 |
| 08056771600897 - CT-3 Immunoscreen Fluoro-Kit™ | 2026-02-09 |
| 08056771600903 - CT-2 Immunoscreen Fluoro-Kit™ | 2026-02-09 |
| 08056771600910 - RS Fluoro-Kit™ | 2026-02-09 |