Alkaline Phosphatase Reagent Set 501-398

GUDID 00812137011855

For the quantitative determination of alkaline phosphatase in human serum. For in vitro diagnostic use only. Serum alkaline phosphatase estimations are of interest in the diagnosis of two groups of conditions; hepatobiliary disease and bone disease associated with increased osteoblastic activity.

CLINICAL DIAGNOSTIC SOLUTIONS, INC.

Alkaline phosphatase (ALP) isoenzyme IVD, kit, enzyme spectrophotometry Alkaline phosphatase (ALP) isoenzyme IVD, kit, enzyme spectrophotometry Alkaline phosphatase (ALP) isoenzyme IVD, kit, spectrophotometry Alkaline phosphatase (ALP) isoenzyme IVD, kit, spectrophotometry Alkaline phosphatase (ALP) isoenzyme IVD, kit, spectrophotometry Alkaline phosphatase (ALP) isoenzyme IVD, kit, spectrophotometry Alkaline phosphatase (ALP) isoenzyme IVD, kit, spectrophotometry Alkaline phosphatase (ALP) isoenzyme IVD, kit, spectrophotometry Alkaline phosphatase (ALP) isoenzyme IVD, kit, spectrophotometry Alkaline phosphatase (ALP) isoenzyme IVD, kit, spectrophotometry Alkaline phosphatase (ALP) isoenzyme IVD, kit, spectrophotometry Alkaline phosphatase (ALP) isoenzyme IVD, kit, spectrophotometry Alkaline phosphatase (ALP) isoenzyme IVD, kit, spectrophotometry Alkaline phosphatase (ALP) isoenzyme IVD, kit, spectrophotometry Alkaline phosphatase (ALP) isoenzyme IVD, kit, spectrophotometry Alkaline phosphatase (ALP) isoenzyme IVD, kit, spectrophotometry Alkaline phosphatase (ALP) isoenzyme IVD, kit, spectrophotometry
Primary Device ID00812137011855
NIH Device Record Keyb24e0990-607f-44ab-94bc-3a4141f08826
Commercial Distribution StatusIn Commercial Distribution
Brand NameAlkaline Phosphatase Reagent Set
Version Model NumberR1 x 500 mL, R2 x 125 mL
Catalog Number501-398
Company DUNS048144997
Company NameCLINICAL DIAGNOSTIC SOLUTIONS, INC.
Device Count2
DM Exempttrue
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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8004533328
Emailquality@cdsolinc.com
Phone8004533328
Emailquality@cdsolinc.com
Phone8004533328
Emailquality@cdsolinc.com
Phone8004533328
Emailquality@cdsolinc.com
Phone8004533328
Emailquality@cdsolinc.com
Phone8004533328
Emailquality@cdsolinc.com
Phone8004533328
Emailquality@cdsolinc.com
Phone8004533328
Emailquality@cdsolinc.com
Phone8004533328
Emailquality@cdsolinc.com
Phone8004533328
Emailquality@cdsolinc.com
Phone8004533328
Emailquality@cdsolinc.com
Phone8004533328
Emailquality@cdsolinc.com
Phone8004533328
Emailquality@cdsolinc.com
Phone8004533328
Emailquality@cdsolinc.com
Phone8004533328
Emailquality@cdsolinc.com
Phone8004533328
Emailquality@cdsolinc.com
Phone8004533328
Emailquality@cdsolinc.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
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100812137011855 [Primary]
GS100812137012210 [Unit of Use]

FDA Product Code

CJENitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes

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 Date2016-10-12

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