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Teco Diagnostics Total Protein Reagent Set

Primary DI
10673486002201
Brand
Teco Diagnostics Total Protein Reagent Set
Company
TECO DIAGNOSTICS
Model
T528-480
Catalog number
T528-480
Device description
Teco Diagnostics Total Protein Reagent Set is used for the quantitative determination of total protein concentration in human serum.
Published
2023-11-14
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
CEKBiuret (Colorimetric), Total Protein

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CEKBiuret (Colorimetric), Total ProteinClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K864743000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K864743000BIURET (COLORIMETRIC), TOTAL PROTEINTech-Co, Inc.1987-01-13CEK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10673486002201PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1067348600220110673486002201

GMDN Terms#

Term, Definition table
TermDefinition
Total protein 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 total protein in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 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
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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414654010Atellica CH Total Protein_2Siemens Healthcare Diagnostics Inc.CEK2026-03-18
00850053916144IDG/SanzayIDG/SANZAY CorporationCEK2024-01-12
00630414611082Atellica CH Total Protein_2Siemens Healthcare Diagnostics Inc.CEK2023-12-13
00630414306025Atellica CH Total Protein_2Siemens Healthcare Diagnostics Inc.CEK2023-12-13
10673486002171Teco Diagnostics CSF/Urine Protein Reagent SetTECO DIAGNOSTICSCEK2023-11-14
10673486002218Teco Diagnostics Total Protein Reagent Kit for TC-MatrixTECO DIAGNOSTICSCEK2023-11-14
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