FDA.reportPublic FDA data

Teco Diagnostics Calcium Reagent Set

Primary DI
10673486001365
Brand
Teco Diagnostics Calcium Reagent Set
Company
TECO DIAGNOSTICS
Model
C503-480
Catalog number
C503-480
Device description
Teco Diagnostics Calcium Reagent Set is used for the direct, colorimetric determination of calcium in human serum or urine.
Published
2023-07-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CICCresolphthalein Complexone, Calcium

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CICCresolphthalein Complexone, CalciumClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K864741000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K864741000CRESOLPHTHALEIN COMPLEXONE, CALCIUMTech-Co, Inc.1987-01-09CIC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10673486001365PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1067348600136510673486001365

GMDN Terms#

Term, Definition table
TermDefinition
Calcium (Ca2+) IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of calcium (Ca2+) in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
7144631111hello@tecodiagnostics.com

Regulatory Flags#

DUNS number
185067774
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
10673486014068Teco Diagnostics Infectious Mononucleosis (IM) Latex TestIML-50IML-502026-05-21
10673486014051Teco Diagnostics Anti-Streptolysin O (ASO) Reagent SetASO-50ASO-502026-05-07
10673486014037Teco Diagnostics Creatinine (Kinetic) Reagent Kit for TC-Matrix-240C514-650TC2C514-650TC22026-04-30
10673486014044Teco Diagnostics Creatinine (Kinetic) Reagent Kit for TC-Matrix-480C514-650TC4C514-650TC42026-04-30
10673486014020Teco Diagnostics One-Step Urine/Serum Combo Pregnancy Dipstick TestP597-25P597-252026-04-09
10673486014013Teco Diagnostics Chemistry CalibratorTC-CAL-MULTITC-CAL-MULTI2026-03-20
10673486014006Teco Diagnostics One-Step Pregnancy Dipstick TestP595-AP595-A2026-02-12
10673486013993Teco Diagnostics Rapid Fecal Occult Blood (FOB) TestF735-25F735-252026-01-30
10673486013986Teco Diagnostics H. Pylori Card TestH730-50H730-502026-01-27
10673486013979Teco Diagnostics ALT (SGPT) Reagent Set (Colorimetric, Endpoint Method)A526-120A526-1202026-01-19
10673486001013Albumin Reagent SetA502-480A502-4802023-07-07
10673486001020Albumin -BCG method TC-MatrixA502-510TMA502-510TM2023-07-07
10673486002478GLUCOPAD TC-SMART+ Lancets KitG852-E-001G852-E-0012025-06-10
10673486002461GLUCOPAD TC-SMART+ Lancets KitG852-E-001G852-E-0012025-05-14
10673486013580Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTC-MatrixTC-Matrix2025-05-28
10673486013726Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTC-MATRIX-160TC-MATRIX-1602025-05-28
10673486013894Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTC-Matrix-240TC-Matrix-2402025-05-28
10673486013962Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTC-Matrix-480TC-Matrix-4802025-05-28
10673486000726Teco Diagnostics Glucopad Blood Glucose Test StripsGlucopad Blood Glucose Test StripsG852-B-0022024-12-19
10673486002454Teco Diagnostics One-Step Urine/Serum Combo Pregnancy Card TestP596-25P596-252024-12-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414654041Atellica CH CaSiemens Healthcare Diagnostics Inc.CIC2026-04-08
00850053916076IDG/SanzayIDG/SANZAY CorporationCIC2024-01-15
00811727016065Pointe Calcium ReagentHORIBA INSTRUMENTS INCORPORATEDCIC2021-01-30
00630414550916ADVIA® Chemistry Multi-Drug Urine Controls 1,2Siemens Healthcare Diagnostics Inc.CIC2020-09-24
00811727015754Pointe Calcium Arsenazo for BS480HORIBA INSTRUMENTS INCORPORATEDCIC2020-05-28
00852169008119ClearChem Diagnostics Inc. CalciumCLEARCHEM DIAGNOSTICS INC.CIC2018-04-30
00630414595672Atellica CH CaSiemens Healthcare Diagnostics Inc.CIC2017-12-21
00817274022559JAS DiagnosticsDREW SCIENTIFIC, INC.CIC2017-06-09
00812137011923Calcium Arsenazo III ReagentCLINICAL DIAGNOSTIC SOLUTIONS, INC.CIC2016-10-12
00817439020345Calcium / BS480Medtest Dx, Inc.CIC2016-09-27
15099590010126AUBeckman Coulter, Inc.CIC2016-09-24
15099590020057AUBeckman Coulter, Inc.CIC2016-09-24
00842768014123Dimension® Flex® reagent cartridge CASiemens Healthcare Diagnostics Inc.CIC2016-09-24
00842768015618Dimension Vista® Flex® reagent cartridge CASiemens Healthcare Diagnostics Inc.CIC2016-09-24
00657498000625Calcium (CPC) LiquiColor®STANBIO LABORATORY, L.P.CIC2016-09-24
00630414508405ADVIA® Chemistry Calcium ReagentsSiemens Healthcare Diagnostics Inc.CIC2016-09-24
00630414538716ADVIA® Chemistry Calcium Reagents, Concentrated (CA_c)-CPCSiemens Healthcare Diagnostics Inc.CIC2016-09-24
00630414555904ADVIA® Chemistry CPC Calcium ReagentsSiemens Healthcare Diagnostics Inc.CIC2016-09-24
04015630901999CalciumRoche Diagnostics GmbHCIC2016-09-20
04015630921348CalciumRoche Diagnostics GmbHCIC2016-09-20
04015630921355CalciumRoche Diagnostics GmbHCIC2016-09-20
05060500090432Synermed®INFRARED LABORATORY SYSTEMS LLCCIC2016-09-20
05060500090449Synermed®INFRARED LABORATORY SYSTEMS LLCCIC2016-09-20
05060500090456Synermed®INFRARED LABORATORY SYSTEMS LLCCIC2016-09-20
05055273200898CaRANDOX LABORATORIES LIMITEDCIC2016-09-16
05055273200911CaRANDOX LABORATORIES LIMITEDCIC2016-09-16
05055273200928CaRANDOX LABORATORIES LIMITEDCIC2016-09-16
00817274021088JAS DiagnosticsDREW SCIENTIFIC, INC.CIC2016-09-09
00817274021095JAS DiagnosticsDREW SCIENTIFIC, INC.CIC2016-09-09
00817274021101JAS DiagnosticsDREW SCIENTIFIC, INC.CIC2016-09-09