FDA.reportPublic FDA data

Scantibodies Laboratory, Inc.

Primary DI
00850002253153
Brand
Scantibodies Laboratory, Inc.
Company
SCANTIBODIES LABORATORY, INC.
Model
3KG556
Device description
Calcitonin IRMA (Coated Tube)
Published
2019-05-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
K060578000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K060578000CALCITONIN IMMUNORADIOMETRIC ASSAY (IRMA) (COATED TUBE VERSION)Scantibodies Laboratory, Inc.2006-08-30JKR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850002253153PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850002253153008500022531538500022531530850002253153

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

Regulatory Flags#

DUNS number
087577680
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850002253115Scantibodies Laboratory, Inc.3KG0562019-05-20
00850002253122Scantibodies Laboratory, Inc.3KG6002019-05-20
00850002253139Scantibodies Laboratory, Inc.3KG0132019-05-20
00850002253160Scantibodies Laboratory, Inc.3KG0112019-05-20

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
B24221CALHUE010Calcitonin ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.JKR2017-08-03
04015630940158Elecsys CalcitoninRoche Diagnostics GmbHJKR2017-04-21
08305900070248Calcitonin ELISA [Enzyme-Linked ImmunoSorbent Assay]BIOMERICA, INC.JKR2016-12-07
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