AUTION™ Diluent BAC

GUDID 04987486738084

Consumable for the identification and enumeration of WBC, RBC, Casts, Epithelial Cells, and Bacteria as well as flags for pathologic casts, yeast, cry

ARKRAY USA, INC.

Urine analyser IVD, laboratory, automated
Primary Device ID04987486738084
NIH Device Record Keydc692fa1-78f5-4e6b-b836-7d5c1c617440
Commercial Distribution StatusIn Commercial Distribution
Brand NameAUTION™ Diluent BAC
Version Model Number73808
Company DUNS008171162
Company NameARKRAY USA, INC.
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(855)646-3108
Emailxxx@xxx.xxx
Phone+1(855)646-3108
Emailxxx@xxx.xxx
Phone+1(855)646-3108
Emailxxx@xxx.xxx
Phone+1(855)646-3108
Emailxxx@xxx.xxx
Phone+1(855)646-3108
Emailxxx@xxx.xxx
Phone+1(855)646-3108
Emailxxx@xxx.xxx
Phone+1(855)646-3108
Emailxxx@xxx.xxx
Phone+1(855)646-3108
Emailxxx@xxx.xxx
Phone+1(855)646-3108
Emailxxx@xxx.xxx
Phone+1(855)646-3108
Emailxxx@xxx.xxx
Phone+1(855)646-3108
Emailxxx@xxx.xxx
Phone+1(855)646-3108
Emailxxx@xxx.xxx
Phone+1(855)646-3108
Emailxxx@xxx.xxx
Phone+1(855)646-3108
Emailxxx@xxx.xxx
Phone+1(855)646-3108
Emailxxx@xxx.xxx

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104987486738084 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KQOAUTOMATED URINALYSIS SYSTEM

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 Date2016-09-23

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00015482771027 - SPOTCHEM™ II Uric Acid2024-05-31 Strip description for the invitro quantitative determination of uric acid concentration in human plasma from whole blood samples
00015482771034 - SPOTCHEM™ II Total Cholesterol2024-05-31 Strip description for the invitro quantitative determination of total cholesterol in human plasma from whole blood samples
00015482771041 - SPOTCHEM™ II Triglycerides2024-05-31 Strip is for invitro quantitative determination of triglycerides in human plasma from whole blood samples
00015482771058 - SPOTCHEM™ II BUN2024-05-31 Strip description for the invitro quantitative determination of blood urea nitrogen in human plasma from whole blood samples
00015482771065 - SPOTCHEM™ II Total Bilirubin2024-05-31 Strip description for the invitro quantitative determination of total bilirubin concentration in human plasma from whole blood s
00015482771072 - SPOTCHEM™ II Calcium2024-05-31 Strip description for the invitro quantitative determination of calcium concentration in human plasma from whole blood samples

Trademark Results [AUTION]

Mark Image

Registration | Serial
Company
Trademark
Application Date
AUTION
AUTION
79384190 not registered Live/Pending
ARKRAY, Inc.
2023-08-21
AUTION
AUTION
79346928 not registered Live/Pending
ARKRAY, Inc.
2022-03-23
AUTION
AUTION
75520515 2713700 Live/Registered
ARKRAY, INC.
1998-07-17

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