FDA.reportPublic FDA data

Teco Diagnostics Chloride Reagent Set TC Matrix

Primary DI
10673486001341
Brand
Teco Diagnostics Chloride Reagent Set TC Matrix
Company
TECO DIAGNOSTICS
Model
C501-580TM
Catalog number
C501-580TM
Device description
Teco Diagnostics Chloride Reagent Set TC Matrix is used for the quantitative colorimetric determination of chloride in human serum on TC Matrix analyzers.
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
CHJMercuric Thiocyanate, Colorimetry, Chloride

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CHJMercuric Thiocyanate, Colorimetry, ChlorideClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K883386000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K883386000CHLORIDETech-Co, Inc.1988-10-06CHJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10673486001341PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1067348600134110673486001341

GMDN Terms#

Term, Definition table
TermDefinition
Chloride (Cl-) 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 chloride (Cl-) 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
714-463-1111hello@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
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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
10673486001334Teco Diagnostics Chloride Reagent SetTECO DIAGNOSTICSCHJ2023-07-25
EABA40000221Piccolo Electrolyte PanelABAXIS, INC.CHJ2016-09-23
EABA40000231Piccolo MetLyte 8 PanelABAXIS, INC.CHJ2016-09-23
EABA40000241Piccolo Basic Metabolic PanelABAXIS, INC.CHJ2016-09-23
EABA40000271Piccolo Renal Function PanelABAXIS, INC.CHJ2016-09-23
EABA40000281Piccolo Comprehensive Metabolic PanelABAXIS, INC.CHJ2016-09-23
EABA40000311Piccolo Basic Metabolic Panel PlusABAXIS, INC.CHJ2016-09-23
EABA40000341Piccolo MetLyte Plus CRPABAXIS, INC.CHJ2016-09-23
EABA40000371Piccolo MetLac 12 PanelABAXIS, INC.CHJ2016-09-23
00657498000632Chloride LiquiColor®STANBIO LABORATORY, L.P.CHJ2016-09-23
00817274021170JAS DiagnosticsDREW SCIENTIFIC, INC.CHJ2016-09-09