Tomato 74245
GUDID 00816879021240
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 | 00816879021240 |
| NIH Device Record Key | cb2ede29-1851-4cce-8217-14ef98216d2e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tomato |
| Version Model Number | F025 |
| Catalog Number | 74245 |
| 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 | 00816879021240 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K841651
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 [Tomato]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TOMATO 97907452 not registered Live/Pending |
Fang Xing Co., Ltd. 2023-04-26 |
 TOMATO 90846386 not registered Live/Pending |
TOMATO, LLC 2021-07-23 |
 TOMATO 88005256 not registered Dead/Abandoned |
Shenzhen Gaofeijie Technology Co.,Ltd. 2018-06-19 |
 TOMATO 87955994 5655718 Live/Registered |
Tuyajie 2018-06-11 |
 TOMATO 86575451 4841396 Live/Registered |
NIXTEK LIMITED 2015-03-25 |
 TOMATO 86238092 4628598 Live/Registered |
Beijing Tongchuang Wangxun Technology Co.,Ltd. 2014-04-01 |
 TOMATO 86115118 4563327 Live/Registered |
Tomato Glasses 2013-11-11 |
 TOMATO 85003203 3927120 Dead/Cancelled |
Cadieux, Paul 2010-03-31 |
 TOMATO 79378724 not registered Live/Pending |
SENAPT LIMITED 2023-04-25 |
 TOMATO 78391908 not registered Dead/Abandoned |
The Tomato Music Works, Limited 2004-03-26 |
 TOMATO 78391901 3104842 Dead/Cancelled |
BENEVOLENT PARTNERS L.P. 2004-03-26 |
 TOMATO 78391887 3008652 Dead/Cancelled |
BENEVOLENT PARTNERS L.P. 2004-03-26 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.