POINTE SCIENTIFIC Chemistry Control, Level 1 & 2 C7592-100

GUDID 00811727010735

Multiple clinical chemistry analyte IVD, control

Primary Device ID	00811727010735
NIH Device Record Key	92152385-172c-4a36-b8e8-02a0c31a0379
Commercial Distribution Status	In Commercial Distribution
Brand Name	POINTE SCIENTIFIC Chemistry Control, Level 1 & 2
Version Model Number	C7592-100
Catalog Number	C7592-100
Company DUNS	045623154
Company Name	POINTE SCIENTIFIC, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius

Device Issuing Agency	Device ID
GS1	00811727010735 [Primary]

JJY	Multi-Analyte Controls, All Kinds (Assayed)

Steralize Prior To Use	false
Device Is Sterile	false

00811727015709 - Pointe Alkaline Phosphatase on the BS480	2023-07-06 Pointe Alkaline Phosphatase packaged for the BS480 Analyzer. 3x60mL, 3x15mL kit. For the quantitative determination of alkaline
00811727015723 - Pointe Amylase on BS480 Analyzer	2023-07-06 Pointe Amylase packaged for use on the BS480 Analyzer. 6x20mL kit. For the quantitative kinetic determination of a-amylase activ
00811727015730 - Pointe AST on the BS480 Analyzer	2023-07-06 Pointe AST packaged for use on the BS480 Analyzer. 5x60mL, 5x15mL Kit. For the quantitative determination of Aspartate Aminotran
00811727015754 - Pointe Calcium Arsenazo for BS480	2023-07-06 Pointe Calcium Arsenazo packaged for the BS480 analyzer. 6x60mL Kit. For the quantitative determination of Calcium in serum or h
00811727015778 - Pointe Cholesterol on BS480	2023-07-06 Pointe Cholesterol packaged to use on the BS480 Analyzer. 8x60mL Kit. For the quantitative determination of Total Cholesterol in
00811727015792 - Pointe Carbon Dioxide on the BS480	2023-07-06 Pointe Carbon Dioxide packaged for use on the BS480 analyzer. 4x40mL Kit. For the quantitative determination of Carbon Dioxide
00811727015839 - Pointe GGT on BS480	2023-07-06 Pointe GGT Reagent packaged for use on the BS480. 4x40mL 4x10mL Kit. For the quantitative kinetic determination of gamma glutamy
00811727015846 - Pointe Glucose Hexokinase for BS480	2023-07-06 Pointe Glucose Hexokinase Reagent packaged for use on the BS480. 8x60 mL Kit. For the in vitro quantitative measurement of gluco