301-3

GUDID 10858512007065

Liquid Urine Control for Microscopic and High Specific Gravity - Positive, 250 ml. 18 month open vial stability when stored at 2-8° C. Contains Polystyrene and Latex.

ALTA DIAGNOSTICS INC

Multiple urine analyte IVD, control
Primary Device ID10858512007065
NIH Device Record Key4d23d4b2-a0cc-47b6-8ca8-71a33de9297e
Commercial Distribution StatusIn Commercial Distribution
Version Model Number301-3
Catalog Number301-3
Company DUNS859323297
Company NameALTA DIAGNOSTICS 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 Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone775-283-5780
Emailtechnical@altadiagnostics.com

Device Dimensions

Total Volume250 Milliliter

Operating and Storage Conditions

Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110858512007065 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JJWUrinalysis Controls (Assayed And Unassayed)

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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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 - NA2019-04-08Liquid Urine Control for Microscopic and High Specific Gravity - Positive, 250 ml. 18 month open vial stability when stored at 2-8° C. Contains Polystyrene and Latex.
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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