Procalcitonin LiquiColor 2300-060

GUDID 00657498001950

Stanbio Procalcitonin (PCT) LiquiColor® is intended for the quantitative determination of PCT in human serum samples, EDTA or lithium heparin plasma samples by latex enhanced immunoturbidimetric method. This test is used in conjunction with other laboratory tests and clinical examinations to aid in the risk assessment of ill patients on their initial hospital admission for the potential development of sepsis and/ or septic shock.

STANBIO LABORATORY, L.P.

Procalcitonin (PCT) IVD, reagent
Primary Device ID00657498001950
NIH Device Record Key86e8dce9-77e4-4f3f-a61a-53af2ecdeafa
Commercial Distribution StatusIn Commercial Distribution
Brand NameProcalcitonin LiquiColor
Version Model Number2300-060
Catalog Number2300-060
Company DUNS045361136
Company NameSTANBIO LABORATORY, L.P.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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
GS100657498001950 [Primary]

FDA Product Code

PTFAssay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-06-26

Devices Manufactured by STANBIO LABORATORY, L.P.

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00657498002346 - HGB Controls - Normal2021-04-08 A single level reference control intended for use on Hemo Control Hemoglobin Measuring system.
00657498002353 - HGB Controls - Normal2021-04-08 A single level reference control intended for use on Hemo Control Hemoglobin Measuring system.
00657498002360 - HGB Controls - High2021-04-08 A single level reference control intended for use on Hemo Control Hemoglobin Measuring system.
00657498002377 - HGB Controls - High2021-04-08 A single level reference control intended for use on Hemo Control Hemoglobin Measuring system.
00657498001806 - Standard 12020-03-02 To provide calibration points for the Sodium, Potassium, and Chloride electrodes on the ISE module of Roche Cobas® Chemistry Sy

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