Detector UA 10

GUDID 20722355002204

Urine Reagent Strips (URS) for Urinalysis are firm plastic strips to which several different reagent areas are affixed

IMMUNOSTICS COMPANY, INC

Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, colorimetric dipstick, rapid Multiple urine analyte IVD, kit, rapid colorimetric, clinical Multiple urine analyte IVD, kit, rapid colorimetric, clinical Multiple urine analyte IVD, kit, rapid colorimetric, clinical Multiple urine analyte IVD, kit, rapid colorimetric, clinical Multiple urine analyte IVD, kit, rapid colorimetric, clinical Multiple urine analyte IVD, kit, rapid colorimetric, clinical Multiple urine analyte IVD, kit, rapid colorimetric, clinical Multiple urine analyte IVD, kit, rapid colorimetric, clinical Multiple urine analyte IVD, kit, rapid colorimetric, clinical Multiple urine analyte IVD, kit, rapid colorimetric, clinical Multiple urine analyte IVD, kit, rapid colorimetric, clinical
Primary Device ID20722355002204
NIH Device Record Key736b3984-df71-4c6f-8d91-e4c017de750a
Commercial Distribution StatusIn Commercial Distribution
Brand NameDetector UA 10
Version Model NumberIDU-10
Company DUNS119214195
Company NameIMMUNOSTICS COMPANY, INC
Device Count100
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
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

Phone+1(732)918-0770
Emailtechnical@immunostics.com
Phone+1(732)918-0770
Emailtechnical@immunostics.com
Phone+1(732)918-0770
Emailtechnical@immunostics.com
Phone+1(732)918-0770
Emailtechnical@immunostics.com
Phone+1(732)918-0770
Emailtechnical@immunostics.com
Phone+1(732)918-0770
Emailtechnical@immunostics.com
Phone+1(732)918-0770
Emailtechnical@immunostics.com
Phone+1(732)918-0770
Emailtechnical@immunostics.com
Phone+1(732)918-0770
Emailtechnical@immunostics.com
Phone+1(732)918-0770
Emailtechnical@immunostics.com
Phone+1(732)918-0770
Emailtechnical@immunostics.com
Phone+1(732)918-0770
Emailtechnical@immunostics.com
Phone+1(732)918-0770
Emailtechnical@immunostics.com
Phone+1(732)918-0770
Emailtechnical@immunostics.com
Phone+1(732)918-0770
Emailtechnical@immunostics.com
Phone+1(732)918-0770
Emailtechnical@immunostics.com
Phone+1(732)918-0770
Emailtechnical@immunostics.com
Phone+1(732)918-0770
Emailtechnical@immunostics.com
Phone+1(732)918-0770
Emailtechnical@immunostics.com
Phone+1(732)918-0770
Emailtechnical@immunostics.com
Phone+1(732)918-0770
Emailtechnical@immunostics.com
Phone+1(732)918-0770
Emailtechnical@immunostics.com
Phone+1(732)918-0770
Emailtechnical@immunostics.com
Phone+1(732)918-0770
Emailtechnical@immunostics.com
Phone+1(732)918-0770
Emailtechnical@immunostics.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature

Device Identifiers

Device Issuing AgencyDevice ID
GS110722355002221 [Primary]
GS120722355002204 [Package]
Contains: 10722355002221
Package: [24 Units]
In Commercial Distribution
GS180722355002220 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JREREFRACTOMETER FOR CLINICAL USE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-12-22
Device Publish Date2016-09-26

Devices Manufactured by IMMUNOSTICS COMPANY, INC

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10722355001309 - Detector hCG2023-07-06 For the qualitative detection of hCG in urine
10722355001316 - Detector hCG2023-07-06 For the qualitative detection of hCG in urine
10722355001330 - Detector hCG Stick2023-07-06 For the qualitative detection of hCG in urine
10722355001347 - Detector hCG Stick2023-07-06 For the qualitative detection of hCG in urine
10722355001354 - Detector hCG Stick2023-07-06 For the qualitative detection of hCG in urine
10722355001361 - Detector hCG Combi2023-07-06 For the qualitative detection of hCG in serum or urine
10722355001378 - Detector hCG Combi2023-07-06 For the qualitative detection of hCG in serum or urine
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