Teco Diagnostics Hemoglobin A1c (HbA1c) Reagent Set G560-125

GUDID 10673486001792

Teco Diagnostics Hemoglobin A1c (HbA1c) Reagent Set is for the quantitative determination of Hemoglobin A1c (HbA1c) in human blood.

TECO DIAGNOSTICS

Glycated haemoglobin (HbA1c) IVD, reagent
Primary Device ID10673486001792
NIH Device Record Key6d236357-dbbb-45b7-a54b-69e18769469f
Commercial Distribution StatusIn Commercial Distribution
Brand NameTeco Diagnostics Hemoglobin A1c (HbA1c) Reagent Set
Version Model NumberG560-125
Catalog NumberG560-125
Company DUNS185067774
Company NameTECO DIAGNOSTICS
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone7144631111
Emailhello@tecodiagnostics.com
Phone7144631111
Emailhello@tecodiagnostics.com
Phone7144631111
Emailhello@tecodiagnostics.com
Phone7144631111
Emailhello@tecodiagnostics.com
Phone7144631111
Emailhello@tecodiagnostics.com
Phone7144631111
Emailhello@tecodiagnostics.com
Phone7144631111
Emailhello@tecodiagnostics.com
Phone7144631111
Emailhello@tecodiagnostics.com
Phone7144631111
Emailhello@tecodiagnostics.com
Phone7144631111
Emailhello@tecodiagnostics.com
Phone7144631111
Emailhello@tecodiagnostics.com
Phone7144631111
Emailhello@tecodiagnostics.com
Phone7144631111
Emailhello@tecodiagnostics.com
Phone7144631111
Emailhello@tecodiagnostics.com
Phone7144631111
Emailhello@tecodiagnostics.com
Phone7144631111
Emailhello@tecodiagnostics.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110673486001792 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LCPAssay, Glycosylated Hemoglobin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-23
Device Publish Date2023-11-15

Devices Manufactured by TECO DIAGNOSTICS

10673486000528 - Teco Diagnostics TC-Thunderbolt Automated Urine Analyzer System2024-06-14 Teco Diagnostics TC-Thunderbolt Automated Urine Analyzer System is an in vitro diagnostic device used to automate the urine chem
10673486000498 - Teco Diagnostics Uritek TC-720+ Urine Chemistry Test System2024-06-13 Teco Diagnostics Uritek TC-720+ Urine Chemistry Test System consists of the Uritek TC-720+ Urine Analyzer and the Teco Diagnosti
10673486000511 - Teco Diagnostics Uritek TC-201 Urine Chemistry Test System2024-06-12 Teco Diagnostics Uritek TC-201 Urine Chemistry Test System consists of the Uritek TC-201 Urine Chemistry Analyzer and the Teco D
10673486002430 - Teco Diagnostics C-Reactive Protein (CRP) Reagent Set2024-04-10 Teco Diagnostics C-Reactive Protein (CRP) Reagent Set is used for the qualitative and semi-quantitative measurement of C-reactiv
10673486002447 - Teco Diagnostics Anti-Streptolysin O (ASO) Reagent Set2024-04-10 Teco Diagnostics Anti-Streptolysin O (ASO) Reagent Set is for the qualitative and semi-quantitative measurement of antibodies to
10673486002423 - Teco Diagnostics Rheumatoid Factor (RF) Reagent Set2024-04-09 Teco Diagnostics Rheumatoid Factor (RF) Reagent Set is for the qualitative and semi-quantitative measurement of RF in human seru
10673486002416 - Teco Diagnostics Urine Reagent Strips (URS-1G)2024-04-01 Teco Diagnostics Urine Reagent Strips (URS-1G) are for in vitro semi-quantitative detection of glucose in urine. The URS-1G str
10673486002393 - Teco Diagnostics H. pylori Card Test2024-01-24 Teco Diagnostics H. pylori Card Test is an immunochromatographic assay for the qualitative determination of IgG antibodies speci

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.