Monobind AccuBind AFP, CEA & PSA VAST ELISA Kit - 192 Wells 8425-300B

GUDID 00816870020426

MONOBIND, INC.

Alpha-fetoprotein (AFP) IVD, kit, radioimmunoassay
Primary Device ID00816870020426
NIH Device Record Key898cce33-1790-492e-abb8-4191d5eca95b
Commercial Distribution StatusIn Commercial Distribution
Brand NameMonobind AccuBind AFP, CEA & PSA VAST ELISA Kit - 192 Wells
Version Model Number8425-300
Catalog Number8425-300B
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
GS100816870020426 [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.

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00816870020648 - Monobind AccuBind PSA Extra Sensitive ELISA Kit - 192 Wells2020-02-06
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