Teco Diagnostics Calcium Reagent Set C503-480

GUDID 10673486001365

Teco Diagnostics Calcium Reagent Set is used for the direct, colorimetric determination of calcium in human serum or urine.

TECO DIAGNOSTICS

Calcium (Ca2+) IVD, reagent
Primary Device ID10673486001365
NIH Device Record Keyd27d7f45-7acd-4f57-a4e7-df6d30b93a80
Commercial Distribution StatusIn Commercial Distribution
Brand NameTeco Diagnostics Calcium Reagent Set
Version Model NumberC503-480
Catalog NumberC503-480
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
Phone7144631111
Emailhello@tecodiagnostics.com
Phone7144631111
Emailhello@tecodiagnostics.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110673486001365 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CICCresolphthalein Complexone, Calcium

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-02
Device Publish Date2023-07-25

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