| Primary Device ID | 00862696000289 |
| NIH Device Record Key | 0746e3aa-eaf3-4b62-9741-0043f9744e59 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BG Analytics Software |
| Version Model Number | 0 |
| Company DUNS | 076574078 |
| Company Name | ASSOCIATES OF CAPE COD, INC. |
| 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 | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00862696000289 [Primary] |
| JQP | Calculator/Data Processing Module, For Clinical Use |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-09-21 |
| Device Publish Date | 2020-09-11 |
| 00862696000289 - BG Analytics Software | 2020-09-21a calculator/data processing module for clinical use described as electronic device intended to store, retrieve, and process laboratory data. |
| 00862696000289 - BG Analytics Software | 2020-09-21 a calculator/data processing module for clinical use described as electronic device intended to store, retrieve, and process lab |
| 00862696000227 - Fungitell STAT | 2020-09-09 |
| 00862696000210 - Fungitell® | 2018-07-30 Assay for (1-3)-β-D-Glucan in Serum |
| 00862696000203 - Fungitell® | 2018-06-29 Assay for (1-3)-β-D-Glucan in Serum |