PrisMatic ELISA Analyzer IN013

GUDID 00816870020068

MONOBIND, INC.

Enzyme immunoassay (EIA) analyser IVD
Primary Device ID00816870020068
NIH Device Record Key1b14aa16-e511-44ba-8acc-4f1209d66686
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrisMatic ELISA Analyzer
Version Model NumberIN013
Catalog NumberIN013
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
GS100816870020068 [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.

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00816870020051 - NeoEldex ELISA Analyzer2024-09-23
00816870020068 - PrisMatic 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

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