UALB Reagent Kit 10225-4

GUDID 00386100002213

Microalbumin Reagent Kit for use with EasyRA Analyzers

MEDICA CORPORATION

Microalbumin IVD, kit, enzyme spectrophotometry
Primary Device ID00386100002213
NIH Device Record Key1c3ed15f-dec8-40b7-a432-0638194495cb
Commercial Distribution StatusIn Commercial Distribution
Brand NameUALB Reagent Kit
Version Model Number10225-4
Catalog Number10225-4
Company DUNS112942404
Company NameMEDICA CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone781-275-4892
Emailtechnicalsupport@medicacorp.com
Phone781-275-4892
Emailtechnicalsupport@medicacorp.com
Phone781-275-4892
Emailtechnicalsupport@medicacorp.com
Phone781-275-4892
Emailtechnicalsupport@medicacorp.com
Phone781-275-4892
Emailtechnicalsupport@medicacorp.com
Phone781-275-4892
Emailtechnicalsupport@medicacorp.com
Phone781-275-4892
Emailtechnicalsupport@medicacorp.com
Phone781-275-4892
Emailtechnicalsupport@medicacorp.com
Phone781-275-4892
Emailtechnicalsupport@medicacorp.com
Phone781-275-4892
Emailtechnicalsupport@medicacorp.com
Phone781-275-4892
Emailtechnicalsupport@medicacorp.com
Phone781-275-4892
Emailtechnicalsupport@medicacorp.com
Phone781-275-4892
Emailtechnicalsupport@medicacorp.com
Phone781-275-4892
Emailtechnicalsupport@medicacorp.com
Phone781-275-4892
Emailtechnicalsupport@medicacorp.com
Phone781-275-4892
Emailtechnicalsupport@medicacorp.com
Phone781-275-4892
Emailtechnicalsupport@medicacorp.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
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
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
GS100386100002213 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DCFAlbumin, Antigen, Antiserum, Control

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-03-11
Device Publish Date2019-02-14

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