Pointe Scientific, Inc. H7506-6

GUDID 00811727011497

Reagent intended for use as human hemoglobin controls for the cyanmethemoglobin hemoglobin procedure 3 x 2ml

POINTE SCIENTIFIC, INC.

Total haemoglobin (totHb) IVD, control
Primary Device ID00811727011497
NIH Device Record Keyd707eb09-9c56-44b7-a716-048bad42481b
Commercial Distribution StatusIn Commercial Distribution
Brand NamePointe Scientific, Inc.
Version Model NumberH7506-6
Catalog NumberH7506-6
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
GS100811727011497 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JPKMixture, Hematology Quality Control

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.]

00811727014634Albumin Reagent, for the quantitative determination of Albumin in serum. Size: 1 x 2L
00811727014627Albumin Reagent, for the quantitative determination of Albumin in serum. Size: 14 x 100mL
00811727014610AST Reagent, for the quantitative determination of Aspartate Aminotransferase (AST) in human ser
00811727014603ALT Reagent, for the quantitative determination of Alanine Aminotransferase in serum. Size: 1 x
00811727014597Alkaline Phosphatase Reagent, for the quantitative determination of alkaline phosphatase in huma
00811727014580Homocysteine Control Kit, is intended to be used as an assayed quality control serum when used f
00811727014573Liquid Stable 2-Part Homocysteine Reagent, intended for in vitro quantitative determination of t
00811727014566Liquid Hemoglobin A1c Control Set, The HbA1c controls are reference controls consisting of human
00811727014559Liquid Hemoglobin A1c Calibrator Set, This product is for the purpose of calibrating results in
00811727014542Hemoglobin A1c Reagent, for the quantitative determination of Hemoglobin A1c (HbA1c) in human bl
00811727014535Hemoglobin A1c Reagent, for the quantitative determination of Hemoglobin A1c (HbA1c) in human bl
00811727014528Hemoglobin Reagent, for the quantitative determination of Hemoglobin in whole blood. Size: 1 x 5
00811727014511Glucose-6-Phosphate Dehydrogenase (G6PD) Lyse. Size: 1 x 100 mL
00811727014498Creatinine Enzymatic Reagent, for the quantitative enzymatic determination of creatinine in seru
00811727014481Creatinine Enzymatic Reagent, for the quantitative enzymatic determination of creatinine in seru
00811727014474Creatinine Enzymatic, for the quantitative enzymatic determination of creatinine in serum and ur
00811727014467Uric Acid Reagent, for the quantitative determination of Uric Acid in serum. For in vitro diagn
00811727014450Uric Acid Reagent, for the quantitative determination of Uric Acid in serum. For in vitro diagn
00811727014443Triglycerides Reagent, for the in vitro quantitative determination of Triglycerides in serum or
00811727014436Triglycerides Reagent, for the in vitro quantitative determination of Triglycerides in serum or
00811727014429Triglycerides Reagent, for the in vitro quantitative determination of Triglycerides in serum or
00811727014405Total Protein Standard, intended for use as an total protein standard for standardization or cal
00811727014399Total Protein Reagent, for the quantitative determination of total protein concentration in seru
00811727014382Total Protein Reagent, for the quantitative determination of total protein concentration in seru
00811727014375Phosphorus Standard, intended for use as an phosphorus standard for standardization or calibrati
00811727014368Phosphorus Reagent, for the quantitative determination of Inorganic Phosphorus in serum. Size: 1
00811727014351Phosphorus Reagent, for the quantitative determination of Inorganic Phosphorus in serum. Size: 1
00811727014344Lactate Dehydrogenase (LD/LDH) Reagent, for the in vitro quantitative kinetic determination of l
00811727014337Lactate Dehydrogenase (LD/LDH) Reagent, for the in vitro quantitative kinetic determination of l
00811727014320Lactate Dehydrogenase (LD/LDH) Reagent, for the in vitro quantitative kinetic determination of l
00811727014313Lactate Dehydrogenase (LD/LDH) Reagent, for the in vitro quantitative kinetic determination of l
00811727014306HDL Cholesterol Standard, for use as a cholesterol standard for standardization or calibration o
00811727014290HDL Reagent, for the quantitative determination of High Density Lipoprotein (HDL) in Cholesterol
00811727014283GGT Reagent, for the quantitative kinetic determination of gamma glutamyl transferase (GGT) acti
00811727014276γ-Glutamyl Transferase Reagent, For the quantitative kinetic determination of gamma glutamyl tr
00811727014269γ-Glutamyl Transferase (GGT) Reagent, for the quantitative kinetic determination of gamma gluta
00811727014146For in vitro diagnostic use only. The Chemistry Control is to be used for monitoring the accurac
00811727014122Reagent for the quantitative determination of creatinine in serum. For in vitro diagnostic use
00811727014115Reagent for the quantitative determination of creatinine in serum. For in vitro diagnostic use
00811727014108Reagent for the quantitative determination of creatinine in serum. For in vitro diagnostic use
00811727014092Reagent for the quantitative determination of creatinine in serum. For in vitro diagnostic use
00811727014085Reagent for the quantitative determination of creatinine in serum. For in vitro diagnostic use
00811727014078Reagent for the quantitative determination of creatinine in serum. For in vitro diagnostic use
00811727014061Reagent for the quantitative determination of Calcium in serum or heparinized plasma. 1 x 500 ml
00811727014054Reagent for the quantitative determination of Calcium in serum or heparinized plasma. 1 x 120 ml
00811727014047For the quantitative determination of creatine kinase activity in serum. 1 x 30 ml
00811727014030Reagent for the quantitative determination of creatine kinase activity in serum. 1 x 120 ml
00811727014023Reagent intended for use as an creatinine standard for standardization or calibration of modifie
00811727014016Reagent for the quantitative determination of Total Cholesterol in serum. 1 x 500 ml
00811727014009Reagent for the quantitative determination of Total Cholesterol in serum. 1 x 120 ml

Trademark Results [Pointe Scientific, Inc.]

Mark Image

Registration | Serial
Company
Trademark
Application Date
POINTE SCIENTIFIC, INC.
POINTE SCIENTIFIC, INC.
78656241 3185944 Dead/Cancelled
Pointe Scientific, Inc.
2005-06-22

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