Pointe Scientific, Inc. Total Protein HT928-3000

GUDID 00811727014832

Pointe Total Protein Reagent is for the quantitative determination of total protein concentration in serum. 1 x 2L, 1 x 1L

POINTE SCIENTIFIC, INC.

Total protein IVD, reagent
Primary Device ID00811727014832
NIH Device Record Key57b19218-d5b1-4ffc-ac26-a7fd993b0c4d
Commercial Distribution StatusIn Commercial Distribution
Brand NamePointe Scientific, Inc. Total Protein
Version Model NumberHT928-3000
Catalog NumberHT928-3000
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 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100811727014832 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CEKBiuret (Colorimetric), Total Protein

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-08-31

On-Brand Devices [Pointe Scientific, Inc. Total Protein]

00811727015112Pointe Scientific, Inc. Total Protein Reagent is for the quantitative determination of total pro
00811727014832Pointe Total Protein Reagent is for the quantitative determination of total protein concentratio
00811727013101Total Protein Reagent is for the quantitative determination of total protein concentration in se
00811727012005Pointe Scientific, Inc. Total Protein Reagent for the quantitative determination of total protei
00811727011992Pointe Scientific, Inc. Total Protein Reagent for the quantitative determination of total protei
00811727011985Pointe Scientific, Inc. Total Protein Reagent for the quantitative determination of total protei

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