FDA.reportPublic FDA data

Teco Diagnostics Cholinesterase Reagent Set

Primary DI
10673486001488
Brand
Teco Diagnostics Cholinesterase Reagent Set
Company
TECO DIAGNOSTICS
Model
C511-60
Catalog number
C511-60
Device description
Teco Diagnostics Cholinesterase Reagent Set is used for in vitro diagnostic use in the quantitative kinetic determination of cholinesterase in human serum, plasma, or whole blood.
Published
2023-07-26
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
DIHColorimetry, Cholinesterase

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DIHColorimetry, CholinesteraseClinical Toxicology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K914171000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K914171000IN VITRO DIAGNOSTIC REGEANT SET,CHOLINESTERASETech Intl. Co.1991-12-18DIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10673486001488PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1067348600148810673486001488

GMDN Terms#

Term, Definition table
TermDefinition
Cholinesterase dibucaine number (percentage inhibition) 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 the dibucaine number or percentage inhibition of cholinesterase activity by dibucaine in a clinical specimen.

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
714-463-1111hello@tecodiagnostics.com

Regulatory Flags#

DUNS number
185067774
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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10673486013580Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTC-MatrixTC-Matrix2025-05-28
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10673486000726Teco Diagnostics Glucopad Blood Glucose Test StripsGlucopad Blood Glucose Test StripsG852-B-0022024-12-19
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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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06971674862949BIOBASEBiobase Biodustry(Shandong)Co., Ltd.DIH2023-07-24
06971674862956BIOBASEBiobase Biodustry(Shandong)Co., Ltd.DIH2023-07-24
06971674862963BIOBASEBiobase Biodustry(Shandong)Co., Ltd.DIH2023-07-24
06971674862970BIOBASEBiobase Biodustry(Shandong)Co., Ltd.DIH2023-07-24
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06971674863038BIOBASEBiobase Biodustry(Shandong)Co., Ltd.DIH2023-07-24
06971674863045BIOBASEBiobase Biodustry(Shandong)Co., Ltd.DIH2023-07-24
06971674863052BIOBASEBiobase Biodustry(Shandong)Co., Ltd.DIH2023-07-24
00630414611044Atellica CH Cholinesterase_2Siemens Healthcare Diagnostics Inc.DIH2023-06-29
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08800055732985ARENA StarARUM DENTISTRY Co., Ltd.DIH2023-03-31
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10758750000241VITROSORTHO-CLINICAL DIAGNOSTICS, INC.DIH2020-04-18
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07613336133620Cholinesterase Gen.2Roche Diagnostics GmbHDIH2020-03-05
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