Pointe Scientific HA965-480

GUDID 00811727012906

Total amylase IVD, kit, enzyme spectrophotometry

Primary Device ID	00811727012906
NIH Device Record Key	1312baf2-b46e-4784-9424-553320210238
Commercial Distribution Status	In Commercial Distribution
Brand Name	Pointe Scientific
Version Model Number	HA965-480
Catalog Number	HA965-480
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
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius

Device Issuing Agency	Device ID
GS1	00811727012906 [Primary]

CIJ	Saccharogenic, Amylase

Steralize Prior To Use	false
Device Is Sterile	false

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00811727012944	Total Bilirubin reagent for the quantitative determination of total bilirubin in serum on Hitach
00811727012937	Direct Bilirubin reagent for the quantitative determination of direct bilirubin in serum on Hita
00811727012920	Base wash solution, 12 x 67ml
00811727012913	HDL reagent for the quantitative determination high-density lipoprotein cholesterol in human ser
00811727012906	Amylase reagent for the quantitative kinetic determination of a-amylase activity in human serum.
00811727012890	AST reagent for the quantitative determination of Aspartate Aminotransferase (AST) in human seru
00811727012883	ALT reagent for the quantitative determination of alanine aminotransferase in serum on Hitachi a
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00811727012425	ISE Standard - Low For the standardization of Sodium, Potassium and Chloride on Ion Selective El