Pointe Scientific, Inc. Calcium HC902-3000

GUDID 00811727014719

Calcium Reagent, For the quantitative determination of calcium in serum on Hitachi analyzers. For in vitro diagnostic use only. Size: 1 x 2L, 1 x 1L

POINTE SCIENTIFIC, INC.

Calcium (Ca2+) IVD, reagent
Primary Device ID00811727014719
NIH Device Record Keya3645b85-8809-4f81-ad4f-d97d1bcbb25f
Commercial Distribution StatusIn Commercial Distribution
Brand NamePointe Scientific, Inc. Calcium
Version Model NumberHC902-3000
Catalog NumberHC902-3000
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
GS100811727014719 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CICCresolphthalein Complexone, Calcium

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. Calcium]

00811727014986Pointe Scientific, Inc. Calcium Reagent is for the quantitative determination of calcium in seru
00811727014719Calcium Reagent, For the quantitative determination of calcium in serum on Hitachi analyzers. Fo

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