Early Discovery
GUDID 20722355002747
Fecal Occult Blood IVD, Guaiac
IMMUNOSTICS COMPANY, INC
Faecal occult blood IVD, kit, rapid colorimetric, clinical| Primary Device ID | 20722355002747 |
| NIH Device Record Key | 0557e4bf-06bd-42b9-9b3c-62c85de87041 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Early Discovery |
| Version Model Number | HSED-3 |
| Company DUNS | 119214195 |
| Company Name | IMMUNOSTICS COMPANY, INC |
| Device Count | 3 |
| 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 | false |
| OTC Over-The-Counter | true |
Customer Support Contacts
| 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 | |
| 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 |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Do not refrigerate or freeze. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not refrigerate or freeze. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not refrigerate or freeze. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not refrigerate or freeze. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not refrigerate or freeze. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not refrigerate or freeze. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not refrigerate or freeze. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not refrigerate or freeze. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not refrigerate or freeze. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not refrigerate or freeze. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not refrigerate or freeze. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not refrigerate or freeze. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not refrigerate or freeze. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not refrigerate or freeze. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not refrigerate or freeze. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not refrigerate or freeze. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not refrigerate or freeze. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not refrigerate or freeze. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not refrigerate or freeze. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not refrigerate or freeze. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not refrigerate or freeze. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not refrigerate or freeze. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not refrigerate or freeze. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not refrigerate or freeze. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not refrigerate or freeze. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not refrigerate or freeze. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10722355002740 [Primary] |
| GS1 | 20722355002747 [Package] Contains: 10722355002740 Package: Case of 30 [30 Units] In Commercial Distribution |
| GS1 | 80722355002749 [Unit of Use] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K022755
FDA Product Code
| KHE | REAGENT, OCCULT BLOOD |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2022-11-28 |
| Device Publish Date | 2016-09-23 |
Devices Manufactured by IMMUNOSTICS COMPANY, INC
| 20722355001122 - hema-screen | 2025-03-31 Fecal Occult Blood Reagent, Guaiac |
| 10722355001156 - hema-screen SPECIFIC | 2025-03-31 Immunological Fecal Occult Blood test |
| 10722355001163 - Detector C-Reactacol | 2025-03-31 A rapid color enhanced latex slide test for the detection of C-Reactive Protein |
| 10722355001170 - Detector C-Reactacol | 2025-03-31 A rapid color enhanced latex slide test for the detection of C-Reactive Protein |
| 10722355001187 - Detector Lex-CRP | 2025-03-31 A rapid undiluted latex slide test for the detection of C-Reactive Protein |
| 10722355001194 - Detector Lex-CRP | 2025-03-31 A rapid undiluted latex slide test for the detection of C-Reactive Protein |
| 10722355001200 - Detector Color IM | 2025-03-31 A simple color enhanced slide test for the detection of infectious mononucleosis |
| 10722355001217 - Detector Color IM | 2025-03-31 A simple color enhanced slide test for the detection of infectious mononucleosis |
Trademark Results [Early Discovery]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EARLY DISCOVERY 87911845 5582599 Live/Registered |
Immunostics Inc. 2018-05-08 |
 EARLY DISCOVERY 86631221 not registered Dead/Abandoned |
IMMUNOSTICS INC. 2015-05-15 |
 EARLY DISCOVERY 85734124 not registered Dead/Abandoned |
Immunostics Inc 2012-09-20 |
 EARLY DISCOVERY 77096866 not registered Dead/Abandoned |
Immunostics Inc. 2007-02-01 |
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