Monobind AccuBind NT4 ELISA Kit - 480 Wells 2625-300D

GUDID 00816870021232

MONOBIND, INC.

Neonatal thyroxine (neonatal T4) IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00816870021232
NIH Device Record Key91c5f96f-de5e-4aca-b337-18d5b17a5e4d
Commercial Distribution StatusIn Commercial Distribution
Brand NameMonobind AccuBind NT4 ELISA Kit - 480 Wells
Version Model Number2625-300
Catalog Number2625-300D
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

Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature

Device Identifiers

Device Issuing AgencyDevice ID
GS100816870021232 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CDXRadioimmunoassay, total thyroxine

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 Date2019-02-11

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