Pointe Scientific HC902-576

GUDID 00811727012968

Calcium reagent for the quantitative determination of calcium in serum on Hitachi analyzers. For in vitro diagnostic use only. 6 x 66ml, 6 x 30ml

POINTE SCIENTIFIC, INC.

Calcium (Ca2+) IVD, reagent
Primary Device ID00811727012968
NIH Device Record Key2ea53f5c-6f16-46e0-a0a3-6f9822f48a19
Commercial Distribution StatusIn Commercial Distribution
Brand NamePointe Scientific
Version Model NumberHC902-576
Catalog NumberHC902-576
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
GS100811727012968 [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

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