FDA.reportPublic FDA data

Calcitonin ELISA [Enzyme-Linked ImmunoSorbent Assay]

Primary DI
08305900070248
Brand
Calcitonin ELISA [Enzyme-Linked ImmunoSorbent Assay]
Company
BIOMERICA, INC.
Model
7024
Device description
The Biomerica Calcitonin ELISA is intended for the quantitative determination of Calcitonin in human serum. This assay is intended for in vitro diagnostic use.
Published
2016-12-07
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
JKRRadioimmunoassay, Calcitonin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JKRRadioimmunoassay, CalcitoninClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K982491000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K982491000SANGUI BIOTECH, INC. CALCITONIN ELISA KITSangui Biotech, Inc.1998-09-03JKR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08305900070248PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08305900070248083059000702488305900070248

GMDN Terms#

Term, Definition table
TermDefinition
Calcitonin IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the quantitative measurement of calcitonin in a clinical specimen, using an enzyme immunoassay (EIA) method.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 949 645 2111info@biomerica.com

Regulatory Flags#

DUNS number
067647321
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336171509Elecsys CalcitoninRoche Diagnostics GmbHJKR2026-06-01
07613336188064Elecsys CalcitoninRoche Diagnostics GmbHJKR2026-06-01
00816870023694Calcitonin AccuLite CLIA Test System -192 WellsMONOBIND, INC.JKR2024-09-13
00816870023700Calcitonin AccuLite CLIA Test System - 96 WellsMONOBIND, INC.JKR2024-09-13
00816870023717Calcitonin AccuBind ELISA Test System - 192 WellsMONOBIND, INC.JKR2024-09-13
00816870023724Calcitonin AccuBind ELISA Test System - 96 WellsMONOBIND, INC.JKR2024-09-13
04048474036480Calcitonin ELISADRG Instruments Gesellschaft mit beschränkter HaftungJKR2023-08-31
00083059070248Calcitonin ELISA [Enzyme-Linked ImmunoSorbent Assay]BIOMERICA, INC.JKR2020-07-01
00630414284736ADVIA Centaur CalcitoninSiemens Healthcare Diagnostics Inc.JKR2019-07-05
00630414284743Atellica IM CalcitoninSiemens Healthcare Diagnostics Inc.JKR2019-07-05
00840239036483Calcitonin ELISADRG International IncJKR2019-06-10
00850002253153Scantibodies Laboratory, Inc.SCANTIBODIES LABORATORY, INC.JKR2019-05-20
B24221CALHUE010Calcitonin ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.JKR2017-08-03
04015630940158Elecsys CalcitoninRoche Diagnostics GmbHJKR2017-04-21
00630414953120IMMULITE® Systems CONTROL CalcitoninSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJKR2016-09-24
00630414953618IMMULITE / IMMULITE® 1000 Systems CAL Calcitonin Sample DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJKR2016-09-24
00630414961156IMMULITE® 2000 Systems CAL CalcitoninSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJKR2016-09-24
00630414963730IMMULITE / IMMULITE® 1000 Systems CAL CalcitoninSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJKR2016-09-24
04015630934799Elecsys Calcitonin ImmunoassayRoche Diagnostics GmbHJKR2016-09-20
30014613333937MicroVueQUIDEL CORPORATIONJKR2016-09-15