323-26-1

GUDID 30858512007144

Liquid Human Spinal Fluid Control Level 1, 2 ml. 18 month open vial stability when stored at 2-8° C.

ALTA DIAGNOSTICS INC

Multiple clinical chemistry analyte IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control
Primary Device ID30858512007144
NIH Device Record Key1d9d5ece-5382-4412-9535-df30ac65a045
Commercial Distribution StatusIn Commercial Distribution
Version Model Number323-26-1
Catalog Number323-26-1
Company DUNS859323297
Company NameALTA DIAGNOSTICS INC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone775-283-5780
Emailtechnical@altadiagnostics.com
Phone775-283-5780
Emailtechnical@altadiagnostics.com
Phone775-283-5780
Emailtechnical@altadiagnostics.com
Phone775-283-5780
Emailtechnical@altadiagnostics.com
Phone775-283-5780
Emailtechnical@altadiagnostics.com
Phone775-283-5780
Emailtechnical@altadiagnostics.com
Phone775-283-5780
Emailtechnical@altadiagnostics.com
Phone775-283-5780
Emailtechnical@altadiagnostics.com
Phone775-283-5780
Emailtechnical@altadiagnostics.com
Phone775-283-5780
Emailtechnical@altadiagnostics.com
Phone775-283-5780
Emailtechnical@altadiagnostics.com
Phone775-283-5780
Emailtechnical@altadiagnostics.com
Phone775-283-5780
Emailtechnical@altadiagnostics.com
Phone775-283-5780
Emailtechnical@altadiagnostics.com
Phone775-283-5780
Emailtechnical@altadiagnostics.com
Phone775-283-5780
Emailtechnical@altadiagnostics.com

Device Dimensions

Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter

Operating and Storage Conditions

Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110858512007140 [Primary]
GS130858512007144 [Package]
Contains: 10858512007140
Package: Box [6 Units]
In Commercial Distribution

FDA Product Code

DFITotal Spinal-Fluid, 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 Date2019-04-08
Device Publish Date2019-03-29

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30858512007014 - NA2019-04-08 Liquid Urine Control Dipstick - Positive, 20 ml. 8 week open vial stability at room temperature. 18 month open vial stability wh
10858512007034 - NA2019-04-08 Liquid Urine Control Dipstick - Negative, 30 ml. 8 week open vial stability at room temperature. 18 month open vial stability wh
30858512007045 - NA2019-04-08 Liquid Urine Control Dipstick - Positive, 30 ml. 8 week open vial stability at room temperature. 18 month open vial stability wh
10858512007065 - NA2019-04-08 Liquid Urine Control for Microscopic and High Specific Gravity - Positive, 250 ml. 18 month open vial stability when stored at 2
10858512007072 - NA2019-04-08 Liquid Urine Control for Microscopic and High Specific Gravity - Negative, 250 ml. 18 month open vial stability when stored at 2
30858512007083 - NA2019-04-08 Liquid Urine Control - Level 1, 10 ml. 18 month open vial stability when stored at 2-8° C.
30858512007090 - NA2019-04-08 Liquid Urine Control - Level 2, 10 ml. 18 month open vial stability when stored at 2-8° C.
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