ALT R2 (w/ssa#) 13-A7526-R2-125

GUDID 00811727013774

For the quantitative determination of Alanine Aminotransferase in serum.

POINTE SCIENTIFIC, INC.

Alanine aminotransferase (ALT) IVD, kit, enzyme spectrophotometry
Primary Device ID00811727013774
NIH Device Record Key49309693-b22f-49f9-ae9d-48359ce1b3c9
Commercial Distribution StatusIn Commercial Distribution
Brand NameALT R2 (w/ssa#)
Version Model Number13-A7526-R2-125
Catalog Number13-A7526-R2-125
Company DUNS045623154
Company NamePOINTE SCIENTIFIC, INC.
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

Phone800-445-9853
Emailtechservice@medtest.com
Phone800-445-9853
Emailtechservice@medtest.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

Device Identifiers

Device Issuing AgencyDevice ID
GS100811727013774 [Primary]

FDA Product Code

CKANadh Oxidation/Nad Reduction, Alt/Sgpt

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 Date2016-08-31

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