Intact-PTH [Parathyroid Hormone] ELISA [Enzyme-Linked ImmunoSorbent Assay]

GUDID 08305900070224

The Biomerica Intact-PTH ELISA is intended for the quantitative determination of Intact-PTH (Parathyroid Hormone) in human serum. This assay is intended for in vitro diagnostic use.

BIOMERICA, INC.

Parathyroid hormone (PTH) IVD, kit, enzyme immunoassay (EIA) Parathyroid hormone (PTH) IVD, kit, enzyme immunoassay (EIA) Parathyroid hormone (PTH) IVD, kit, enzyme immunoassay (EIA) Parathyroid hormone (PTH) IVD, kit, enzyme immunoassay (EIA) Parathyroid hormone (PTH) IVD, kit, enzyme immunoassay (EIA) Parathyroid hormone (PTH) IVD, kit, enzyme immunoassay (EIA) Parathyroid hormone (PTH) IVD, kit, enzyme immunoassay (EIA) Parathyroid hormone (PTH) IVD, kit, enzyme immunoassay (EIA) Parathyroid hormone (PTH) IVD, kit, enzyme immunoassay (EIA) Parathyroid hormone (PTH) IVD, kit, enzyme immunoassay (EIA)
Primary Device ID08305900070224
NIH Device Record Key74edd2fe-1b64-4124-870f-047c191c157b
Commercial Distribution StatusIn Commercial Distribution
Brand NameIntact-PTH [Parathyroid Hormone] ELISA [Enzyme-Linked ImmunoSorbent Assay]
Version Model Number7022
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
Phone+1 949 645 2111
Emailinfo@biomerica.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108305900070224 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CEWRadioimmunoassay, Parathyroid Hormone

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-12-23
Device Publish Date2016-12-07

On-Brand Devices [Intact-PTH [Parathyroid Hormone] ELISA [Enzyme-Linked ImmunoSorbent Assay]]

08305900070224The Biomerica Intact-PTH ELISA is intended for the quantitative determination of Intact-PTH (Par
00083059070224The Biomerica Intact-PTH ELISA is intended for the quantitative determination of Intact-PTH (Par
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.