HGB Controls - High 3063-003

GUDID 00657498002360

A single level reference control intended for use on Hemo Control Hemoglobin Measuring system.

STANBIO LABORATORY, L.P.

Total haemoglobin (totHb) IVD, control Total haemoglobin (totHb) IVD, control Total haemoglobin (totHb) IVD, control Total haemoglobin (totHb) IVD, control Total haemoglobin (totHb) IVD, control Total haemoglobin (totHb) IVD, control Total haemoglobin (totHb) IVD, control Total haemoglobin (totHb) IVD, control Total haemoglobin (totHb) IVD, control Total haemoglobin (totHb) IVD, control Total haemoglobin (totHb) IVD, control Total haemoglobin (totHb) IVD, control Total haemoglobin (totHb) IVD, control Total haemoglobin (totHb) IVD, control Total haemoglobin (totHb) IVD, control Total haemoglobin (totHb) IVD, control
Primary Device ID00657498002360
NIH Device Record Key168f3e11-8e4e-4e59-9e82-49c21212532e
Commercial Distribution StatusIn Commercial Distribution
Brand NameHGB Controls - High
Version Model Number3063-003
Catalog Number3063-003
Company DUNS045361136
Company NameSTANBIO LABORATORY, L.P.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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

Phone18005315535
Emailstanbiolab@ekfdiagnostics.com
Phone18005315535
Emailstanbiolab@ekfdiagnostics.com
Phone18005315535
Emailstanbiolab@ekfdiagnostics.com
Phone18005315535
Emailstanbiolab@ekfdiagnostics.com
Phone18005315535
Emailstanbiolab@ekfdiagnostics.com
Phone18005315535
Emailstanbiolab@ekfdiagnostics.com
Phone18005315535
Emailstanbiolab@ekfdiagnostics.com
Phone18005315535
Emailstanbiolab@ekfdiagnostics.com
Phone18005315535
Emailstanbiolab@ekfdiagnostics.com
Phone18005315535
Emailstanbiolab@ekfdiagnostics.com
Phone18005315535
Emailstanbiolab@ekfdiagnostics.com
Phone18005315535
Emailstanbiolab@ekfdiagnostics.com
Phone18005315535
Emailstanbiolab@ekfdiagnostics.com
Phone18005315535
Emailstanbiolab@ekfdiagnostics.com
Phone18005315535
Emailstanbiolab@ekfdiagnostics.com
Phone18005315535
Emailstanbiolab@ekfdiagnostics.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
GS100657498002360 [Primary]

FDA Product Code

JJYMulti-Analyte Controls, All Kinds (Assayed)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-04-08
Device Publish Date2021-03-31

On-Brand Devices [HGB Controls - High]

00657498002377A single level reference control intended for use on Hemo Control Hemoglobin Measuring system.
00657498002360A single level reference control intended for use on Hemo Control Hemoglobin Measuring system.

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