Rubella IgG AccuBind ELISA Test System - 192 Wells 6325-300B

GUDID 00816870024172

MONOBIND, INC.

Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00816870024172
NIH Device Record Key85521a5e-c7d7-4d6a-bb63-51afca7bbb82
Commercial Distribution StatusIn Commercial Distribution
Brand NameRubella IgG AccuBind ELISA Test System - 192 Wells
Version Model Number6325-300
Catalog Number6325-300B
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 Kittrue
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 Perscriptiontrue
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 Dimensions

Width7.75 Inch
Width7.75 Inch
Width7.75 Inch
Width7.75 Inch
Width7.75 Inch
Width7.75 Inch
Width7.75 Inch
Width7.75 Inch
Width7.75 Inch
Width7.75 Inch
Width7.75 Inch
Width7.75 Inch
Width7.75 Inch
Width7.75 Inch
Width7.75 Inch
Width7.75 Inch
Width7.75 Inch

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100816870024172 [Primary]

FDA Product Code

LFXENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA

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
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

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.