Monobind AccuLite AFP CLIA Kit - 192 Wells 1975-300B

GUDID 00816870022147

MONOBIND, INC.

Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay
Primary Device ID00816870022147
NIH Device Record Key7624840d-0522-48c1-b56b-c806822ae0f3
Commercial Distribution StatusIn Commercial Distribution
Brand NameMonobind AccuLite AFP CLIA Kit - 192 Wells
Version Model Number1975-300
Catalog Number1975-300B
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

Width7.75 Inch

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature

Device Identifiers

Device Issuing AgencyDevice ID
GS100816870022147 [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

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.