POINTE SCIENTIFIC AMMONIA A7553-85

GUDID 00811727010254

This reagent is intended for the enzymatic measurement of ammonia in plasma. For in vitro diagnostic use only.

POINTE SCIENTIFIC, INC.

Ammonia IVD, kit, enzyme spectrophotometry
Primary Device ID00811727010254
NIH Device Record Key306a3dbc-e29d-43aa-8513-f3b08a4acd88
Commercial Distribution StatusIn Commercial Distribution
Brand NamePOINTE SCIENTIFIC AMMONIA
Version Model NumberA7553-85
Catalog NumberA7553-85
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
GS100811727010254 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JIFEnzymatic Method, Ammonia

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 AMMONIA]

00811727010254This reagent is intended for the enzymatic measurement of ammonia in plasma. For in vitro diagn
00811727010247This reagent is intended for the enzymatic measurement of ammonia in plasma. For in vitro diagn

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