NeoEldex ELISA Analyzer IN009

GUDID 00816870020051

MONOBIND, INC.

Enzyme immunoassay (EIA) analyser IVD
Primary Device ID00816870020051
NIH Device Record Key6ab56cc4-670d-4693-b6dc-d7b865559d30
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeoEldex ELISA Analyzer
Version Model NumberIN009
Catalog NumberIN009
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 Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
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
Phone+1(949)951-2665
Emailinfo@monobind.com
Phone+1(949)951-2665
Emailinfo@monobind.com
Phone+1(949)951-2665
Emailinfo@monobind.com
Phone+1(949)951-2665
Emailinfo@monobind.com
Phone+1(949)951-2665
Emailinfo@monobind.com
Phone+1(949)951-2665
Emailinfo@monobind.com
Phone+1(949)951-2665
Emailinfo@monobind.com
Phone+1(949)951-2665
Emailinfo@monobind.com
Phone+1(949)951-2665
Emailinfo@monobind.com
Phone+1(949)951-2665
Emailinfo@monobind.com
Phone+1(949)951-2665
Emailinfo@monobind.com
Phone+1(949)951-2665
Emailinfo@monobind.com
Phone+1(949)951-2665
Emailinfo@monobind.com
Phone+1(949)951-2665
Emailinfo@monobind.com
Phone+1(949)951-2665
Emailinfo@monobind.com
Phone+1(949)951-2665
Emailinfo@monobind.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100816870020051 [Primary]

FDA Product Code

JJQCOLORIMETER, PHOTOMETER, SPECTROPHOTOMETER FOR CLINICAL USE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-09-23
Device Publish Date2024-09-13

Devices Manufactured by MONOBIND, INC.

00816870020006 - NeoLumax CLIA Analyzer2024-09-23
00816870020013 - LuMatic CLIA Analyzer2024-09-23
00816870020044 - Immunoassay Plate Washer2024-09-23
00816870020051 - NeoEldex ELISA Analyzer2024-09-23
00816870020051 - NeoEldex ELISA Analyzer2024-09-23
00816870020068 - PrisMatic ELISA Analyzer2024-09-23
00816870020075 - Autoplex G1 ELISA Analyzer2024-09-23
00816870020082 - Autoplex G2 ELISA + CLIA Analyzer2024-09-23
00816870020402 - PTH Intact AccuBind ELISA Test System - 96 Wells2024-09-23

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.