DEVICE: Detector UA 10 (10722355002221)

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Device Identifier (DI) Information

Detector UA 10
IDU-10

IMMUNOSTICS COMPANY, INC
10722355002221
GS1
100
Urine Reagent Strips (URS) for Urinalysis are firm plastic strips to which several different reagent areas are affixed
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
Yes
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Multiple urine analyte IVD, kit, colorimetric dipstick, rapid A collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative screening of urine for multiple analytes within a short period relative to standard laboratory testing procedures, using a colorimetric dipstick method. This test is commonly used in the laboratory or in point-of-care analyses.
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FDA Product Code

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Product Code Product Code Name
JRE REFRACTOMETER FOR CLINICAL USE
JIL METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE)
JJB AZO-DYES, COLORIMETRIC, BILIRUBIN & ITS CONJUGATES (URINARY, NON-QUANT.)
JIN NITROPRUSSIDE, KETONES (URINARY, NON-QUANT.)
CDM DIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.)
JMA ACID, ASCORBIC, 2,4-DINITROPHENYLHYDRAZINE (SPECTROPHOTOMETRIC)
JMT DIAZO (COLORIMETRIC), NITRITE (URINARY, NON-QUANT)
JIR INDICATOR METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.)
CEN DYE-INDICATOR, PH (URINARY, NON-QUANT.)
LJX TEST, URINE LEUKOCYTE
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Temperature: between 15 and 30 Degrees Celsius
Special Storage Condition, Specify: Store at room temperature
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
September 26, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
20722355002204 24 10722355002221 In Commercial Distribution
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: 80722355002220 CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(732)918-0770
technical@immunostics.com
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