T-3 HYE-5697

GUDID 00840239056979

Multiple thyroid marker IVD, kit, enzyme immunoassay (EIA)

Primary Device ID	00840239056979
NIH Device Record Key	458a1fc0-4cd0-4326-87a1-9831d877ca6f
Commercial Distribution Status	In Commercial Distribution
Brand Name	T-3
Version Model Number	HYE-5697
Catalog Number	HYE-5697
Company DUNS	075150847
Company Name	DRG International Inc
Device Count	1
DM Exempt	false
Pre-market Exempt	true
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	true
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

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 Issuing Agency	Device ID
GS1	00840239056979 [Primary]

CDP	Radioimmunoassay, Total Triiodothyronine

Steralize Prior To Use	false
Device Is Sterile	false

00840239023858 - Free Triiodothyronine (fT3) ELISA	2024-10-01 For the quantitative determination of Free Triiodothyronine (fT3) concentration in human serum
00840239038012 - Free T3 ELISA	2024-10-01 The DRG Free T3 ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of free triiodothyronine (FT
00840239053565 - T3 free	2024-10-01 The DRG:HYBRiD-XL free T3 is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of free Triiodothyronine
00840239038470 - Mumps IgM ELISA	2024-08-28 The Mumps Virus IgM ELISA is intended for the qualitative determination of IgM class antibodies against Mumps Virus in human ser
00840239056979 - T-3	2024-08-21The DRG:Hybrid-XL T3 ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of T3
00840239056979 - T-3	2024-08-21 The DRG:Hybrid-XL T3 ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of T3
00840239035769 - Anti-SS-B ELISA	2023-10-17 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