Almond 74273
GUDID 00816879021349
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 | 00816879021349 |
| NIH Device Record Key | 82a9aa69-06cb-4db0-b309-908c7fe13c94 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Almond |
| Version Model Number | F020 |
| Catalog Number | 74273 |
| 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 | 00816879021349 [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 [Almond]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ALMOND 97748163 not registered Live/Pending |
Almond Franchising Inc. 2023-01-10 |
 ALMOND 97464434 not registered Live/Pending |
Sichuan Kunzhi sports equipment manufacturing Co. ,Ltd 2022-06-17 |
 ALMOND 90787554 not registered Live/Pending |
The Sugar Art 2021-06-22 |
 ALMOND 88722392 not registered Live/Pending |
BIGFOOT VENTURES LLC 2019-12-11 |
 ALMOND 88015831 not registered Dead/Abandoned |
Menusifu, Inc. 2018-06-26 |
 ALMOND 87931541 not registered Live/Pending |
Espro, Inc. 2018-05-22 |
 ALMOND 87330842 not registered Dead/Abandoned |
ALMOND INTERNATIONAL LIMITED 2017-02-09 |
 ALMOND 86711112 not registered Dead/Abandoned |
Cross River Bank, Inc. 2015-07-31 |
 ALMOND 86211226 4613725 Live/Registered |
The Sugar Art Inc. 2014-03-05 |
 ALMOND 85509166 4306418 Live/Registered |
Securifi, Inc. 2012-01-05 |
 ALMOND 79244442 not registered Live/Pending |
Waterbomb Limited 2018-09-20 |
 ALMOND 79188027 not registered Dead/Abandoned |
Schmid, Harald 2016-01-28 |
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