FDA.reportPublic FDA data

Calcitonin ELISA

Primary DI
00840239036483
Brand
Calcitonin ELISA
Company
DRG International Inc
Model
EIA-3648
Catalog number
EIA-3648
Device description
The Calcitonin ELISA is intended for the quantitative determination of Calcitonin in human serum.
Published
2019-06-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
00840239036483PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840239036483008402390364838402390364830840239036483

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(973)564-7555corp@drg-international.com

Regulatory Flags#

DUNS number
075150847
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840239041173ANA Detect ELISAEIA-4117EIA-41172023-08-25
00840239035622ANA-8-Screen ELISAEIA-3562EIA-35622023-08-24
00840239035639ANA-8-Profile ELISAEIA-3563EIA-35632023-08-24
00840239027733ANA Screen IgG ELISA EIA-2773EIA-27732023-08-23
00840239035899Anti-Cardiolipin Screen ELISAEIA-3589EIA-35892023-08-25
00840239035967c-ANCA (PR3) ELISAEIA-3596EIA-35962023-08-25
00840239036025Anti-Lactoferrin ELISAEIA-3602EIA-36022023-08-25
00840239059673Measles Virus IgG Avidity ELISAEIA-5967EIA-59672023-08-26
00840239060594Giardia/Cryptosporidium Ag (stool) ELISA EIA-6059EIA-60592023-08-26
00840239027931Epstein Barr Virus VCA IgG ELISAEIA-2793EIA-27932023-08-24
00840239027948Epstein Barr Virus VCA IgM ELISAEIA-2794EIA-27942023-08-24
00840239027962EBV-EA IgG ELISAEIA-2796EIA-27962023-08-24
00840239028150H. Pylori IgG ELISA EIA-2815EIA-28152023-08-24
00840239033710Gliadin IgG ELISA EIA-3371EIA-33712023-08-24
00840239034670Cryptosporidium Antigen (stool) ELISA EIA-3467EIA-34672023-08-24
00840239034731Entamoeba histolytica Ag (stool) ELISA EIA-3473EIA-34732023-08-24
00840239034779Giardia lamblia Antigen (stool) ELISA EIA-3477EIA-34772023-08-24
00840239035523HGH (Human Growth Hormone) ELISAEIA-3552EIA-35522023-08-24
00840239035615Anti TPO Ab ELISAEIA-3561EIA-35612023-08-24
00840239035646Anti-dsDNA IgM ELISAEIA-3564EIA-35642023-08-24

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
00850002253153Scantibodies Laboratory, Inc.SCANTIBODIES LABORATORY, INC.JKR2019-05-20
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