Monobind AccuBind T3 ELISA Kit - 480 Wells 125-300D

GUDID 00816870021553

MONOBIND, INC.

Total triiodothyronine (TT3) IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00816870021553
NIH Device Record Keycb1ebe95-5bee-45e0-916c-f1ab5f132a79
Commercial Distribution StatusIn Commercial Distribution
Brand NameMonobind AccuBind T3 ELISA Kit - 480 Wells
Version Model Number125-300
Catalog Number125-300D
Company DUNS083155515
Company NameMONOBIND, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(949)951-2665
Emailinfo@monobind.com

Device Dimensions

Width12 Inch

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100816870021553 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Date2019-03-11
Device Publish Date2019-02-27

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