Total Thyroxine (T4) ELISA EIA-1781

GUDID 00840239017819

For the quantitative determination of total thyroxine (T4) concentration in human serum. The test is useful in the diagnosis and treatment of thyroid disorders.

DRG International Inc

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Primary Device ID	00840239017819
NIH Device Record Key	d66e8c5f-835d-4093-a012-28c23616f611
Commercial Distribution Status	In Commercial Distribution
Brand Name	Total Thyroxine (T4) ELISA
Version Model Number	EIA-1781
Catalog Number	EIA-1781
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

Device Dimensions

Total Volume	1 Milliliter
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Total Volume	11 Milliliter
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Total Volume	13 Milliliter
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Total Volume	11 Milliliter
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Total Volume	13 Milliliter
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Total Volume	11 Milliliter
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Total Volume	13 Milliliter
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Total Volume	11 Milliliter
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Total Volume	13 Milliliter
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Total Volume	11 Milliliter
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Total Volume	13 Milliliter
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Total Volume	11 Milliliter
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Total Volume	13 Milliliter
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Total Volume	1 Milliliter
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Total Volume	11 Milliliter
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Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	13 Milliliter
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Total Volume	1 Milliliter
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Total Volume	11 Milliliter
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Device Size Text, specify	0
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Total Volume	13 Milliliter
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Total Volume	1 Milliliter
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Total Volume	11 Milliliter
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Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	13 Milliliter
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Total Volume	1 Milliliter
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Total Volume	11 Milliliter
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Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	13 Milliliter
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Total Volume	1.3 Milliliter
Total Volume	1 Milliliter
Device Size Text, specify	0
Total Volume	11 Milliliter
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Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	13 Milliliter
Device Size Text, specify	0
Total Volume	1.3 Milliliter
Total Volume	1 Milliliter
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Total Volume	11 Milliliter
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Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	13 Milliliter
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Total Volume	1 Milliliter
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Total Volume	11 Milliliter
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Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	13 Milliliter
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Total Volume	1.3 Milliliter
Total Volume	1 Milliliter
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Total Volume	11 Milliliter
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Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	13 Milliliter
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Total Volume	1.3 Milliliter
Total Volume	1 Milliliter
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Total Volume	11 Milliliter
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Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	13 Milliliter
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Total Volume	1 Milliliter
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Total Volume	11 Milliliter
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Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	13 Milliliter
Device Size Text, specify	0
Total Volume	1.3 Milliliter
Total Volume	1 Milliliter
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Total Volume	11 Milliliter
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Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	13 Milliliter
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Total Volume	1.3 Milliliter
Total Volume	1 Milliliter
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Total Volume	11 Milliliter
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Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	13 Milliliter
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Total Volume	1.3 Milliliter
Total Volume	1 Milliliter
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Total Volume	11 Milliliter
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Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	13 Milliliter
Device Size Text, specify	0
Total Volume	1.3 Milliliter
Total Volume	1 Milliliter
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Total Volume	11 Milliliter
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Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	13 Milliliter
Device Size Text, specify	0
Total Volume	1.3 Milliliter
Total Volume	1 Milliliter
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Total Volume	11 Milliliter
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Device Size Text, specify	0
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Total Volume	13 Milliliter
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Total Volume	1 Milliliter
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Total Volume	11 Milliliter
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Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	13 Milliliter
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Total Volume	1.3 Milliliter
Total Volume	1 Milliliter
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Total Volume	11 Milliliter
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	13 Milliliter
Device Size Text, specify	0
Total Volume	1.3 Milliliter
Total Volume	1 Milliliter
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Total Volume	11 Milliliter
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Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	13 Milliliter
Device Size Text, specify	0
Total Volume	1.3 Milliliter
Total Volume	1 Milliliter
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Total Volume	11 Milliliter
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	13 Milliliter
Device Size Text, specify	0
Total Volume	1.3 Milliliter
Total Volume	1 Milliliter
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Total Volume	11 Milliliter
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Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	13 Milliliter
Device Size Text, specify	0
Total Volume	1.3 Milliliter
Total Volume	1 Milliliter
Device Size Text, specify	0
Total Volume	11 Milliliter
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	13 Milliliter
Device Size Text, specify	0
Total Volume	1.3 Milliliter
Total Volume	1 Milliliter
Device Size Text, specify	0
Total Volume	11 Milliliter
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	13 Milliliter
Device Size Text, specify	0
Total Volume	1.3 Milliliter
Total Volume	1 Milliliter
Device Size Text, specify	0
Total Volume	11 Milliliter
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	13 Milliliter
Device Size Text, specify	0
Total Volume	1.3 Milliliter
Total Volume	1 Milliliter
Device Size Text, specify	0
Total Volume	11 Milliliter
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	13 Milliliter
Device Size Text, specify	0
Total Volume	1.3 Milliliter
Total Volume	1 Milliliter
Device Size Text, specify	0
Total Volume	11 Milliliter
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	13 Milliliter
Device Size Text, specify	0
Total Volume	1.3 Milliliter
Total Volume	1 Milliliter
Device Size Text, specify	0
Total Volume	11 Milliliter
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	13 Milliliter
Device Size Text, specify	0
Total Volume	1.3 Milliliter
Total Volume	1 Milliliter

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840239017819 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K991432

FDA Product Code

KLI	Enzyme immunoassay, non-radiolabeled, total thyroxine

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

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00840239035783 - Anti-RNP/Sm ELISA	2023-09-04 Anti-RNP/Sm ELISA is a test system for the quantitative measurement of IgG class autoantibodies against RNP/Sm in human serum or