Anti-Thyroglobulin (Anti-Tg) ELISA EIA-4110

GUDID 00840239041104

The Quantitative Determination of Thyroglobulin (Tg) Autoantibodies in Human Serum or Plasma by a Microplate Enzyme Immunoassay, Colorimetric. Measurements of Tg autoantibodies may aid in the diagnosis of certain thyroid diseases such as Hashimoto’s and Grave’s as well as nontoxic goiter.

DRG International Inc

Thyroglobulin/Thyroid peroxidase antibody (anti-TPO/Microsomal antibody) IVD, kit, enzyme immunoassay (EIA)

Primary Device ID	00840239041104
NIH Device Record Key	85b324fc-aa68-4ede-87ef-c6a55cc8a748
Commercial Distribution Status	In Commercial Distribution
Brand Name	Anti-Thyroglobulin (Anti-Tg) ELISA
Version Model Number	EIA-4110
Catalog Number	EIA-4110
Company DUNS	075150847
Company Name	DRG International 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	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	false
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+1(973)564-7555
Email	corp@drg-international.com
Phone	+1(973)564-7555
Email	corp@drg-international.com
Phone	+1(973)564-7555
Email	corp@drg-international.com
Phone	+1(973)564-7555
Email	corp@drg-international.com
Phone	+1(973)564-7555
Email	corp@drg-international.com
Phone	+1(973)564-7555
Email	corp@drg-international.com
Phone	+1(973)564-7555
Email	corp@drg-international.com
Phone	+1(973)564-7555
Email	corp@drg-international.com
Phone	+1(973)564-7555
Email	corp@drg-international.com
Phone	+1(973)564-7555
Email	corp@drg-international.com
Phone	+1(973)564-7555
Email	corp@drg-international.com
Phone	+1(973)564-7555
Email	corp@drg-international.com
Phone	+1(973)564-7555
Email	corp@drg-international.com
Phone	+1(973)564-7555
Email	corp@drg-international.com
Phone	+1(973)564-7555
Email	corp@drg-international.com
Phone	+1(973)564-7555
Email	corp@drg-international.com
Phone	+1(973)564-7555
Email	corp@drg-international.com
Phone	+1(973)564-7555
Email	corp@drg-international.com
Phone	+1(973)564-7555
Email	corp@drg-international.com
Phone	+1(973)564-7555
Email	corp@drg-international.com
Phone	+1(973)564-7555
Email	corp@drg-international.com
Phone	+1(973)564-7555
Email	corp@drg-international.com
Phone	+1(973)564-7555
Email	corp@drg-international.com
Phone	+1(973)564-7555
Email	corp@drg-international.com
Phone	+1(973)564-7555
Email	corp@drg-international.com
Phone	+1(973)564-7555
Email	corp@drg-international.com
Phone	+1(973)564-7555
Email	corp@drg-international.com
Phone	+1(973)564-7555
Email	corp@drg-international.com
Phone	+1(973)564-7555
Email	corp@drg-international.com
Phone	+1(973)564-7555
Email	corp@drg-international.com
Phone	+1(973)564-7555
Email	corp@drg-international.com
Phone	+1(973)564-7555
Email	corp@drg-international.com
Phone	+1(973)564-7555
Email	corp@drg-international.com
Phone	+1(973)564-7555
Email	corp@drg-international.com
Phone	+1(973)564-7555
Email	corp@drg-international.com
Phone	+1(973)564-7555
Email	corp@drg-international.com
Phone	+1(973)564-7555
Email	corp@drg-international.com
Phone	+1(973)564-7555
Email	corp@drg-international.com
Phone	+1(973)564-7555
Email	corp@drg-international.com
Phone	+1(973)564-7555
Email	corp@drg-international.com
Phone	+1(973)564-7555
Email	corp@drg-international.com
Phone	+1(973)564-7555
Email	corp@drg-international.com
Phone	+1(973)564-7555
Email	corp@drg-international.com
Phone	+1(973)564-7555
Email	corp@drg-international.com
Phone	+1(973)564-7555
Email	corp@drg-international.com
Phone	+1(973)564-7555
Email	corp@drg-international.com
Phone	+1(973)564-7555
Email	corp@drg-international.com
Phone	+1(973)564-7555
Email	corp@drg-international.com
Phone	+1(973)564-7555
Email	corp@drg-international.com
Phone	+1(973)564-7555
Email	corp@drg-international.com
Phone	+1(973)564-7555
Email	corp@drg-international.com
Phone	+1(973)564-7555
Email	corp@drg-international.com
Phone	+1(973)564-7555
Email	corp@drg-international.com
Phone	+1(973)564-7555
Email	corp@drg-international.com
Phone	+1(973)564-7555
Email	corp@drg-international.com
Phone	+1(973)564-7555
Email	corp@drg-international.com
Phone	+1(973)564-7555
Email	corp@drg-international.com

Device Dimensions

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Device Size Text, specify	0
Total Volume	8 Milliliter
Device Size Text, specify	0
Total Volume	20 Milliliter
Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	13 Milliliter
Device Size Text, specify	0
Total Volume	1 Milliliter
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	7 Milliliter
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Total Volume	8 Milliliter
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Device Identifiers

Device Issuing Agency	Device ID
GS1	00840239041104 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K971835

FDA Product Code

DDC	THYROGLOBULIN, ANTIGEN, ANTISERUM, CONTROL

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	2
Public Version Date	2020-03-30
Device Publish Date	2019-03-20

Devices Manufactured by DRG International Inc

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	2024-08-21 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