Primary Device ID | 30014613338383 |
NIH Device Record Key | 866f074c-4894-4f3a-bfc8-021040e0cb49 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Thyretain |
Version Model Number | 40-100100 |
Catalog Number | 40-100100 |
Company DUNS | 117359612 |
Company Name | DIAGNOSTIC HYBRIDS, INC. |
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 | 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 |
Phone | +1(858)552-1100 |
technicalsupport@quidel.com | |
Phone | +1(858)552-1100 |
technicalsupport@quidel.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 30014613338383 [Primary] |
JZO | SYSTEM, TEST, THYROID AUTOANTIBODY |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-03-15 |
Device Publish Date | 2019-03-07 |
30014613338390 | Reaction Buffer |
30014613338383 | GROWTH MEDIUM |
30014613331681 | LUCIFERASE ASSAY SYSTEM |
30014613331667 | TSI MC4 CELLS |
30014613331636 | REFERENCE Control |
30014613331629 | NORMAL SERUM |
30014613331612 | TSI POSITIVE SERUM |
30014613331605 | Thretain TSI Reporter Bioassay 50P |
30014613331599 | THYRETAIN CELL ATTACH SOLUT |
30014613331582 | CELL ATTACHMENT SOLUTION |
30014613331568 | THYRETAIN REACTION BUFFER |
30014613331544 | THYR LUCIFERASE REAGENT SET |
30014613331537 | Thretain TSI Reporter Bioassay 25P |
30014613331520 | THYRETAIN MEDIA SET |
30014613331513 | THYRETAIN CELL AND Control SET |
30014613331506 | THYRETAIN CELLS AND Control SET |
30014613331490 | THYRETAIN CELL & Control SET |
30014613331483 | THYRETAIN GROWTH MEDIUM |
30014613331476 | RSM STARVATION MEDIUM |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() THYRETAIN 77705611 3811849 Live/Registered |
Diagnostic Hybrids, Inc. 2009-04-02 |