Calcitonin ELISA [Enzyme-Linked ImmunoSorbent Assay]

GUDID 08305900070248

The Biomerica Calcitonin ELISA is intended for the quantitative determination of Calcitonin in human serum. This assay is intended for in vitro diagnostic use.

BIOMERICA, INC.

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Primary Device ID08305900070248
NIH Device Record Key7aefee90-652d-48fe-b50e-3ae61b8ffd7d
Commercial Distribution Discontinuation2020-07-01
Commercial Distribution StatusNot in Commercial Distribution
Brand NameCalcitonin ELISA [Enzyme-Linked ImmunoSorbent Assay]
Version Model Number7024
Company DUNS067647321
Company NameBIOMERICA, 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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1 949 645 2111
Emailinfo@biomerica.com
Phone+1 949 645 2111
Emailinfo@biomerica.com
Phone+1 949 645 2111
Emailinfo@biomerica.com
Phone+1 949 645 2111
Emailinfo@biomerica.com
Phone+1 949 645 2111
Emailinfo@biomerica.com
Phone+1 949 645 2111
Emailinfo@biomerica.com
Phone+1 949 645 2111
Emailinfo@biomerica.com
Phone+1 949 645 2111
Emailinfo@biomerica.com
Phone+1 949 645 2111
Emailinfo@biomerica.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108305900070248 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JKRRadioimmunoassay, Calcitonin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-09-02
Device Publish Date2016-12-07

On-Brand Devices [Calcitonin ELISA [Enzyme-Linked ImmunoSorbent Assay]]

00083059070248The Biomerica Calcitonin ELISA is intended for the quantitative determination of Calcitonin in h
08305900070248The Biomerica Calcitonin ELISA is intended for the quantitative determination of Calcitonin in h
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