Crab 74304
GUDID 00816879021387
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 | 00816879021387 |
| NIH Device Record Key | 7d09133d-e9e8-4759-afac-d32422570445 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Crab |
| Version Model Number | F023 |
| Catalog Number | 74304 |
| 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 | 00816879021387 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K831554
FDA Product Code
| DHB | System, Test, Radioallergosorbent (Rast) Immunological |
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 |
On-Brand Devices [Crab]
| 00816879021387 | A substance or reactant intended to be used together with a parent IVD to perform a specific fun |
| 00816879021318 | A substance or reactant intended to be used together with a parent IVD to perform a specific fun |
Trademark Results [Crab]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CRAB 98283192 not registered Live/Pending |
CRAB International Corp 2023-11-23 |
 CRAB 88436145 5926020 Live/Registered |
CHESAPEAKE REGION ACCESSIBLE BOATING, INC. 2019-05-17 |
 CRAB 85743294 4342247 Live/Registered |
Special Services Group, LLC 2012-10-02 |
 CRAB 85067295 3933049 Live/Registered |
Innovation First, Inc. 2010-06-21 |
 CRAB 79185933 not registered Dead/Abandoned |
CRAB Clinical Informatics Ltd 2016-01-26 |
 CRAB 78937887 not registered Dead/Abandoned |
Dircom Inc. 2006-07-26 |
 CRAB 77540929 3586954 Live/Registered |
Cancer Research And Biostatistics 2008-08-06 |
 CRAB 77083518 not registered Dead/Abandoned |
Dircom Inc. 2007-01-16 |
 CRAB 76317782 2682765 Dead/Cancelled |
Cancer Research And Biostatistics 2001-09-26 |
 CRAB 76317781 2682764 Live/Registered |
Cancer Research And Biostatistics 2001-09-26 |
 CRAB 74131415 1737986 Dead/Cancelled |
ECOLMARE SPA 1991-01-18 |
 CRAB 73496686 1342027 Live/Registered |
Chantiers Du Nord et de la MediterraneeS.A. 1984-08-27 |
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