T3 free HYE-5356

GUDID 00840239053565

The DRG:HYBRiD-XL free T3 is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of free Triiodothyronine (T3) in serum and EDTA plasma. Only for use with the DRG:HYBRiD-XL Analyzer.

DRG International Inc

Multiple thyroid marker IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00840239053565
NIH Device Record Key85241cc6-a3eb-4e93-bcf1-70ba3896ebb3
Commercial Distribution StatusIn Commercial Distribution
Brand NameT3 free
Version Model NumberHYE-5356
Catalog NumberHYE-5356
Company DUNS075150847
Company NameDRG International Inc
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone973-564-7555
Emailcorp@drg-international.com
Phone973-564-7555
Emailcorp@drg-international.com
Phone973-564-7555
Emailcorp@drg-international.com
Phone973-564-7555
Emailcorp@drg-international.com
Phone973-564-7555
Emailcorp@drg-international.com
Phone973-564-7555
Emailcorp@drg-international.com
Phone973-564-7555
Emailcorp@drg-international.com
Phone973-564-7555
Emailcorp@drg-international.com
Phone973-564-7555
Emailcorp@drg-international.com
Phone973-564-7555
Emailcorp@drg-international.com
Phone973-564-7555
Emailcorp@drg-international.com
Phone973-564-7555
Emailcorp@drg-international.com
Phone973-564-7555
Emailcorp@drg-international.com
Phone973-564-7555
Emailcorp@drg-international.com
Phone973-564-7555
Emailcorp@drg-international.com
Phone973-564-7555
Emailcorp@drg-international.com
Phone973-564-7555
Emailcorp@drg-international.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100840239053565 [Primary]

FDA Product Code

CDPRadioimmunoassay, Total Triiodothyronine

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-10-01
Device Publish Date2024-09-23

Devices Manufactured by DRG International Inc

00840239023858 - Free Triiodothyronine (fT3) ELISA2024-10-01 For the quantitative determination of Free Triiodothyronine (fT3) concentration in human serum
00840239038012 - Free T3 ELISA2024-10-01 The DRG Free T3 ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of free triiodothyronine (FT
00840239053565 - T3 free2024-10-01The DRG:HYBRiD-XL free T3 is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of free Triiodothyronine (T3) in serum and EDTA plasma. Only for use with the DRG:HYBRiD-XL Analyzer.
00840239053565 - T3 free2024-10-01 The DRG:HYBRiD-XL free T3 is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of free Triiodothyronine
00840239038470 - Mumps IgM ELISA2024-08-28 The Mumps Virus IgM ELISA is intended for the qualitative determination of IgM class antibodies against Mumps Virus in human ser
00840239056979 - T-32024-08-21 The DRG:Hybrid-XL T3 ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of T3
00840239035769 - Anti-SS-B ELISA2023-10-17 Anti-SS-B ELISA is a test system for the quantitative measurement of IgG class autoantibodies against SS-B (La) in human serum o
00840239048882 - Vitamin C (Ascorbic Acid)2023-09-11 This colorimetric microtiter plate assay is suitable for the determination of vitamin C (ascorbic acid) in Li-heparin plasma, se
00084023903579 - Anti-SS-B ELISA 2023-09-04 Anti-SS-B ELISA is a test system for the quantitative measurement of IgG class autoantibodies against SS-B (La) in human serum o

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