Pointe Uric Acid Reagent 16-HU982-308

GUDID 00811727016294

Pointe Uric Acid Reagent packaged for use on the Mindray BA800. 4 x 65ml R1, 3 x 16ml R2. For the quantitative determination of uric acid in serum. For in vitro diagnostic use only.

POINTE SCIENTIFIC, INC.

Uric acid IVD, reagent
Primary Device ID00811727016294
NIH Device Record Key31de2eda-bbce-44ea-b52a-a8619fcf2d45
Commercial Distribution StatusIn Commercial Distribution
Brand NamePointe Uric Acid Reagent
Version Model Number16-HU982-308
Catalog Number16-HU982-308
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@medtestdx.com
Phone800-445-9853
Emailtechservice@medtestdx.com
Phone800-445-9853
Emailtechservice@medtestdx.com
Phone800-445-9853
Emailtechservice@medtestdx.com
Phone800-445-9853
Emailtechservice@medtestdx.com
Phone800-445-9853
Emailtechservice@medtestdx.com
Phone800-445-9853
Emailtechservice@medtestdx.com
Phone800-445-9853
Emailtechservice@medtestdx.com
Phone800-445-9853
Emailtechservice@medtestdx.com
Phone800-445-9853
Emailtechservice@medtestdx.com
Phone800-445-9853
Emailtechservice@medtestdx.com
Phone800-445-9853
Emailtechservice@medtestdx.com
Phone800-445-9853
Emailtechservice@medtestdx.com
Phone800-445-9853
Emailtechservice@medtestdx.com
Phone800-445-9853
Emailtechservice@medtestdx.com
Phone800-445-9853
Emailtechservice@medtestdx.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
GS100811727016294 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KNKAcid, Uric, Uricase (Colorimetric)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-08
Device Publish Date2021-01-30

On-Brand Devices [Pointe Uric Acid Reagent]

00811727016294Pointe Uric Acid Reagent packaged for use on the Mindray BA800. 4 x 65ml R1, 3 x 16ml R2. For
00811727015990Pointe Uric Acid Reagent packaged for use on the Mindray BS480. 4 x 40ml. For the quantitative

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