hema-screen
GUDID 50722355001017
Fecal Occult Blood IVD, Guaiac
IMMUNOSTICS COMPANY, INC
Faecal occult blood IVD, kit, rapid colorimetric, clinical| Primary Device ID | 50722355001017 |
| NIH Device Record Key | a61eaf7d-96f5-4857-8334-37c2eeed8162 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | hema-screen |
| Version Model Number | HS-100 |
| Company DUNS | 119214195 |
| Company Name | IMMUNOSTICS COMPANY, INC |
| Device Count | 100 |
| 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 | true |
| OTC Over-The-Counter | false |
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 *Keep away from heat and light. Do not refrigerate. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat and light. Do not refrigerate. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat and light. Do not refrigerate. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat and light. Do not refrigerate. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat and light. Do not refrigerate. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat and light. Do not refrigerate. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat and light. Do not refrigerate. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat and light. Do not refrigerate. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat and light. Do not refrigerate. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat and light. Do not refrigerate. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat and light. Do not refrigerate. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat and light. Do not refrigerate. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat and light. Do not refrigerate. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat and light. Do not refrigerate. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat and light. Do not refrigerate. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat and light. Do not refrigerate. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat and light. Do not refrigerate. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat and light. Do not refrigerate. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat and light. Do not refrigerate. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat and light. Do not refrigerate. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat and light. Do not refrigerate. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat and light. Do not refrigerate. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat and light. Do not refrigerate. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat and light. Do not refrigerate. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat and light. Do not refrigerate. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat and light. Do not refrigerate. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10722355001019 [Primary] |
| GS1 | 20722355001016 [Package] Contains: 10722355001019 Package: Case of 3 [3 Units] In Commercial Distribution |
| GS1 | 30722355001013 [Package] Contains: 20722355001016 Package: Case of 10 [10 Units] In Commercial Distribution |
| GS1 | 40722355001010 [Package] Contains: 30722355001013 Package: Case of 50 [50 Units] In Commercial Distribution |
| GS1 | 50722355001017 [Package] Contains: 40722355001010 Package: Case of 20 [20 Units] In Commercial Distribution |
| GS1 | 80722355001018 [Unit of Use] |
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 | 3 |
| Public Version Date | 2022-11-28 |
| Device Publish Date | 2016-09-23 |
On-Brand Devices [hema-screen]
| 10722355002818 | Fecal Occult Blood IVD, Guaiac |
| 20722355001047 | Fecal Occult Blood IVD, Guaiac |
| 20722355001030 | Fecal Occult Blood IVD, Guaiac |
| 20722355001023 | Fecal Occult Blood IVD, Guaiac |
| 50722355001017 | Fecal Occult Blood IVD, Guaiac |
| 20722355001009 | Fecal Occult Blood IVD, Guaiac |
| 20722355001122 | Fecal Occult Blood Reagent, Guaiac |
Trademark Results [hema-screen]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HEMA-SCREEN 76167666 2506476 Live/Registered |
STANBIO LABORATORY 2000-11-20 |
 HEMA-SCREEN 75392219 not registered Dead/Abandoned |
IMMUNOSTICS, INC. 1997-11-18 |
 HEMA-SCREEN 74053099 not registered Dead/Abandoned |
IMMUNOSTICS CO., INC. 1990-04-26 |
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