Peanut 74240
GUDID 00816879021226
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of an allergen specific immunoglobulin E (IgE) antibody in a clinical specimen.
HYCOR BIOMEDICAL LLC
Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent| Primary Device ID | 00816879021226 |
| NIH Device Record Key | 3cd621b4-e874-40fd-ba04-7febf8eb5ea3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Peanut |
| Version Model Number | F013 |
| Catalog Number | 74240 |
| Company DUNS | 010558476 |
| Company Name | HYCOR BIOMEDICAL LLC |
| 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 | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | true |
| 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 | false |
Customer Support Contacts
Operating and Storage Conditions
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816879021226 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K830817
FDA Product Code
| DGC | Ige, Antigen, Antiserum, Control |
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 | 2018-07-06 |
| Device Publish Date | 2016-09-26 |
Devices Manufactured by HYCOR BIOMEDICAL LLC
Trademark Results [Peanut]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PEANUT 90746756 not registered Live/Pending |
Villalobos, Kaiulani 2021-06-01 |
 PEANUT 88813201 not registered Live/Pending |
Big One Co. 2020-02-27 |
 PEANUT 88689636 not registered Live/Pending |
Steve's Lures 2019-11-12 |
 PEANUT 88089642 5881231 Live/Registered |
Radio Flyer Inc. 2018-08-23 |
 PEANUT 87931221 not registered Live/Pending |
Espro, Inc. 2018-05-22 |
 PEANUT 86798703 not registered Dead/Abandoned |
Maison J. Battat, Ltee 2015-10-25 |
 PEANUT 86340767 4819325 Live/Registered |
Securifi, Inc. 2014-07-17 |
 PEANUT 85896176 not registered Dead/Abandoned |
Flip Skateboards, Inc. 2013-04-05 |
 PEANUT 85853949 not registered Dead/Abandoned |
Flocast, LLC 2013-02-19 |
 PEANUT 85853946 4504190 Live/Registered |
Flocast, LLC 2013-02-19 |
 PEANUT 85206244 4005804 Dead/Cancelled |
THE TRUSTEE OF THE JEFF DUNHAM TRUST DATED MARCH 24, 2010 2010-12-27 |
 PEANUT 85044342 3870716 Dead/Cancelled |
THE TRUSTEE OF THE JEFF DUNHAM TRUST DATED MARCH 24, 2010 2010-05-20 |
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