| Primary Device ID | 10722355001156 |
| NIH Device Record Key | 03f732ae-ebc4-4246-b3e3-586d3f6763ad |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | hema-screen SPECIFIC |
| Version Model Number | BUF17-25 |
| Company DUNS | 119214195 |
| Company Name | Immunostics Company, Inc |
| Device Count | 25 |
| 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 | 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 |
| Phone | +1(732)918-0770 |
| technical@immunostics.com | |
| Phone | +1(732)918-0770 |
| technical@immunostics.com | |
| Phone | +1(732)918-0770 |
| technical@immunostics.com | |
| Phone | +1(732)918-0770 |
| technical@immunostics.com | |
| Phone | +1(732)918-0770 |
| technical@immunostics.com | |
| Phone | +1(732)918-0770 |
| technical@immunostics.com | |
| Phone | +1(732)918-0770 |
| technical@immunostics.com | |
| Phone | +1(732)918-0770 |
| technical@immunostics.com | |
| Phone | +1(732)918-0770 |
| technical@immunostics.com | |
| Phone | +1(732)918-0770 |
| technical@immunostics.com | |
| Phone | +1(732)918-0770 |
| technical@immunostics.com | |
| Phone | +1(732)918-0770 |
| technical@immunostics.com | |
| Phone | +1(732)918-0770 |
| technical@immunostics.com | |
| Phone | +1(732)918-0770 |
| technical@immunostics.com | |
| Phone | +1(732)918-0770 |
| technical@immunostics.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10722355001156 [Primary] |
| GS1 | 80722355001155 [Unit of Use] |
| KHE | REAGENT, OCCULT BLOOD |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2025-03-31 |
| Device Publish Date | 2016-09-21 |
| 10722355002689 | Immunological Fecal Occult Blood test |
| 20722355001092 | Immunological Fecal Occult Blood test |
| 10722355001088 | Immunological Fecal Occult Blood test |
| 20722355001078 | Immunological Fecal Occult Blood test |
| 10722355001118 | Immunological Fecal Occult Blood test |
| 20722355001108 | Immunological Fecal Occult Blood test |
| 10722355001835 | Immunological Fecal Occult Blood test |
| 10722355001750 | Immunological Fecal Occult Blood test |
| 10722355001156 | Immunological Fecal Occult Blood test |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() HEMA-SCREEN SPECIFIC 78747407 not registered Dead/Abandoned |
Immunostics, Inc. 2005-11-04 |