Monobind AccuBind AFP, hCG & uE3 VAST ELISA Kit - 480 Wells 8525-300D

GUDID 00816870020891

MONOBIND, INC.

Trisomy 21-risk hormone IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00816870020891
NIH Device Record Key2d1b5f62-17c0-4e2f-ac24-0707a4610b9c
Commercial Distribution StatusIn Commercial Distribution
Brand NameMonobind AccuBind AFP, hCG & uE3 VAST ELISA Kit - 480 Wells
Version Model Number8525-300
Catalog Number8525-300D
Company DUNS083155515
Company NameMONOBIND, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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
GS100816870020891 [Primary]

FDA Product Code

LOJKIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER

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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