Detector UA 2GP

GUDID 20722355002914

For rapid detection of multiple analytes in human urine.

IMMUNOSTICS COMPANY, INC

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Primary Device ID20722355002914
NIH Device Record Keycf1829dc-ca1e-4e30-8919-f13f39ffa8ae
Commercial Distribution StatusIn Commercial Distribution
Brand NameDetector UA 2GP
Version Model NumberIDU-2GP
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
Phone+1(732)918-0770
Emailtechnical@immunostics.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Once the canister has been opened, the remaining strips are stable for up to 3 months.
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Once the canister has been opened, the remaining strips are stable for up to 3 months.
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Once the canister has been opened, the remaining strips are stable for up to 3 months.
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Once the canister has been opened, the remaining strips are stable for up to 3 months.
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Once the canister has been opened, the remaining strips are stable for up to 3 months.
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Once the canister has been opened, the remaining strips are stable for up to 3 months.
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Once the canister has been opened, the remaining strips are stable for up to 3 months.
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Once the canister has been opened, the remaining strips are stable for up to 3 months.
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Once the canister has been opened, the remaining strips are stable for up to 3 months.
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Once the canister has been opened, the remaining strips are stable for up to 3 months.
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Once the canister has been opened, the remaining strips are stable for up to 3 months.
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Once the canister has been opened, the remaining strips are stable for up to 3 months.
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Once the canister has been opened, the remaining strips are stable for up to 3 months.
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Once the canister has been opened, the remaining strips are stable for up to 3 months.
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Once the canister has been opened, the remaining strips are stable for up to 3 months.
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Once the canister has been opened, the remaining strips are stable for up to 3 months.
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Once the canister has been opened, the remaining strips are stable for up to 3 months.
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Once the canister has been opened, the remaining strips are stable for up to 3 months.
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Once the canister has been opened, the remaining strips are stable for up to 3 months.
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Once the canister has been opened, the remaining strips are stable for up to 3 months.
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Once the canister has been opened, the remaining strips are stable for up to 3 months.
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Once the canister has been opened, the remaining strips are stable for up to 3 months.
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Once the canister has been opened, the remaining strips are stable for up to 3 months.
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Once the canister has been opened, the remaining strips are stable for up to 3 months.
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Once the canister has been opened, the remaining strips are stable for up to 3 months.
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Once the canister has been opened, the remaining strips are stable for up to 3 months.
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110722355002917 [Primary]
GS120722355002914 [Package]
Contains: 10722355002917
Package: [12 Units]
In Commercial Distribution
GS180722355002916 [Unit of Use]

FDA Product Code

JILMETHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2021-11-10
Device Publish Date2018-11-20

Devices Manufactured by IMMUNOSTICS COMPANY, INC

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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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