Monobind AccuBind TSH ELISA Kit - 480 Wells 325-300D

GUDID 00816870021805

MONOBIND, INC.

Thyroid stimulating hormone (TSH) IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00816870021805
NIH Device Record Keyfca7b7a9-1cca-4530-a874-242db5ed9d8a
Commercial Distribution StatusIn Commercial Distribution
Brand NameMonobind AccuBind TSH ELISA Kit - 480 Wells
Version Model Number325-300
Catalog Number325-300D
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
GS100816870021805 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JLWRADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE

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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