Hytec 74407
GUDID 00816879022865
HYCOR BIOMEDICAL LLC
Multiple allergen-specific immunoglobulin E (IgE) antibody IVD, reagent| Primary Device ID | 00816879022865 |
| NIH Device Record Key | b32a87f3-d4eb-44bd-a7b7-619ac496cbbc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Hytec |
| Version Model Number | Maple/Box Elder |
| Catalog Number | 74407 |
| 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 | false |
| 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
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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816879022865 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K821451
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 | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-05-18 |
| Device Publish Date | 2020-05-08 |
On-Brand Devices [Hytec]
| 00816879022865 | Maple/Box Elder |
| 00816879022858 | MCS Specific Total IgE Conjugate |
| 00816879022841 | Specific IgE Reference Disc |
Trademark Results [Hytec]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HYTEC 98207863 not registered Live/Pending |
Tissuerate Inc. 2023-10-03 |
 HYTEC 86176163 4694448 Live/Registered |
GROZ-BECKERT KG 2014-01-27 |
 HYTEC 79016328 not registered Dead/Abandoned |
Groz-Beckert KG 2004-12-21 |
 HYTEC 78329947 not registered Dead/Abandoned |
Kohler Co. 2003-11-19 |
 HYTEC 77249977 3438555 Dead/Cancelled |
GROZ-BECKERT KG 2007-08-08 |
 HYTEC 75705691 not registered Dead/Abandoned |
BARCLAYS CAPITAL INC. 1999-05-14 |
 HYTEC 74639803 2070997 Dead/Cancelled |
Wilden Pump & Engineering Co. 1995-02-17 |
 HYTEC 73589376 1416521 Dead/Cancelled |
HYTEC, INC. 1986-03-21 |
 HYTEC 73373248 1271247 Dead/Cancelled |
Hackney & Sons, Inc. 1982-07-06 |
 HYTEC 73025058 1013481 Dead/Expired |
HYTEC, INC. 1974-06-24 |
 HYTEC 73023488 1013479 Dead/Cancelled |
HYTEC, INC. 1974-06-06 |
 HYTEC 72441476 0994638 Live/Registered |
OWATONNA TOOL COMPANY 1972-11-17 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.