FDA.reportPublic FDA data

Teco Diagnostics Chemistry Calibrator

Primary DI
10673486014013
Brand
Teco Diagnostics Chemistry Calibrator
Company
TECO DIAGNOSTICS
Model
TC-CAL-MULTI
Catalog number
TC-CAL-MULTI
Device description
Teco Diagnostics Chemistry Calibrator is intended for the calibration of quantitative assays on automated and semi-automated analyzers.
Published
2026-03-20
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
JIXCalibrator, Multi-Analyte Mixture

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JIXCalibrator, Multi-Analyte MixtureClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K073370000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K073370000TC MATRIX CLINICAL CHEMISTRY ANALYZERTeco Diagnostics2008-05-08JJE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10673486014013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1067348601401310673486014013

GMDN Terms#

Term, Definition table
TermDefinition
Multiple-type clinical chemistry analyte profile IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of multiple types of clinical chemistry analytes (e.g., combination of electrolytes, hormones, and proteins) in a clinical specimen, which contribute to or create a full general biochemistry profile.

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
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
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10673486001013Albumin Reagent SetA502-480A502-4802023-07-07
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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
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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
10673486000528Teco Diagnostics TC-Thunderbolt Automated Urine Analyzer SystemTC-ThunderboltTC-Thunderbolt2024-06-06

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Primary DI, Brand, Company table
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