Monobind AccuBind T4 ELISA Kit - 192 Wells 225-300B

GUDID 00816870021669

MONOBIND, INC.

Total thyroxine (TT4) IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00816870021669
NIH Device Record Key3569c8fb-4c4a-4488-8634-1493553b827f
Commercial Distribution StatusIn Commercial Distribution
Brand NameMonobind AccuBind T4 ELISA Kit - 192 Wells
Version Model Number225-300
Catalog Number225-300B
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

Width7.75 Inch

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100816870021669 [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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