323-17-12

GUDID 30858512007137

Liquid Urine Control - Level 1/Level 2, 25 ml. Contains 3 vials Level 1 and 3 vials Level 2. 18 month open vial stability when stored at 2-8° C.

ALTA DIAGNOSTICS INC

Multiple urine analyte IVD, control
Primary Device ID30858512007137
NIH Device Record Key79eb5989-76c8-422e-b1a6-332c6fdde612
Commercial Distribution StatusIn Commercial Distribution
Version Model Number323-17-12
Catalog Number323-17-12
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 Datefalse
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

Device Dimensions

Total Volume25 Milliliter

Operating and Storage Conditions

Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS130858512007137 [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

Devices Manufactured by ALTA DIAGNOSTICS INC

30858512007007 - NA2019-04-08 Liquid Urine Control Dipstick - Negative, 20 ml. 8 week open vial stability at room temperature. 18 month open vial stability wh
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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