| Primary Device ID | 08806133032008 |
| NIH Device Record Key | 74b93905-e7cd-4f14-a240-c093d3915334 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ichroma Reader |
| Version Model Number | FPRR001 |
| Catalog Number | FPRR001 |
| Company DUNS | 689062203 |
| Company Name | Boditech Med 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 | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 732-9180770 |
| agenffon@immunostics.com | |
| Phone | 732-9180770 |
| agenffon@immunostics.com | |
| Phone | 732-9180770 |
| agenffon@immunostics.com | |
| Phone | 732-9180770 |
| agenffon@immunostics.com | |
| Phone | 732-9180770 |
| agenffon@immunostics.com | |
| Phone | 732-9180770 |
| agenffon@immunostics.com | |
| Phone | 732-9180770 |
| agenffon@immunostics.com | |
| Phone | 732-9180770 |
| agenffon@immunostics.com | |
| Phone | 732-9180770 |
| agenffon@immunostics.com | |
| Phone | 732-9180770 |
| agenffon@immunostics.com | |
| Phone | 732-9180770 |
| agenffon@immunostics.com | |
| Phone | 732-9180770 |
| agenffon@immunostics.com | |
| Phone | 732-9180770 |
| agenffon@immunostics.com | |
| Phone | 732-9180770 |
| agenffon@immunostics.com | |
| Phone | 732-9180770 |
| agenffon@immunostics.com | |
| Phone | 732-9180770 |
| agenffon@immunostics.com | |
| Phone | 732-9180770 |
| agenffon@immunostics.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08806133032008 [Primary] |
| OOX | Automated Occult Blood Analyzer |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2025-03-03 |
| Device Publish Date | 2017-10-26 |
| 08806133010099 | FPRR001 |
| 08806133032008 | FPRR001 |