DEVICE: Rapid Response (00722066004364)
Device Identifier (DI) Information
Rapid Response
U5.3-1S100
In Commercial Distribution
U5.3-1S100
BTNX Inc
U5.3-1S100
In Commercial Distribution
U5.3-1S100
BTNX Inc
Rapid Response 5 Parameter Urinalysis Reagent Strips (KET/PH/PRO/GLU/BLD) – 100 tests/ kit are for qualitative or semi-quantitative determination of Ketone, pH, Protein, Glucose and Blood in urine.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
54522 | Urine pH IVD, kit, rapid colorimetric, clinical |
A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative screening of urine to determine pH within a short period relative to standard laboratory testing procedures, using a rapid colorimetric method. This is a rapid test commonly used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.
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Active | false |
54519 | Urine ketone IVD, kit, rapid colorimetric, clinical |
A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative screening of urine for ketones within a short period relative to standard laboratory testing procedures, using a rapid colorimetric method. This is a rapid test commonly used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.
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Active | false |
54523 | Urine protein IVD, kit, rapid colorimetric, clinical |
A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative screening of urine for protein within a short period relative to standard laboratory testing procedures, using a rapid colorimetric method. This is a rapid test commonly used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.
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Active | false |
54515 | Urine blood IVD, kit, rapid colorimetric, clinical |
A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative screening of urine for blood within a short period relative to standard laboratory testing procedures, using a rapid colorimetric method. This is a rapid test commonly used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.
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Active | false |
54518 | Urine glucose IVD, kit, rapid colorimetric, clinical |
A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative screening of urine for glucose within a short period, relative to standard laboratory testing procedures, using a rapid colorimetric method. This is a rapid test commonly used in the laboratory or in point-of-care analyses to aid clinicians in the diagnosis and monitoring of diabetes. It is not intended to be used for self-testing.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
JIO | Blood, Occult, Colorimetric, In Urine |
JIR | Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) |
JIN | Nitroprusside, Ketones (Urinary, Non-Quant.) |
JIL | Method, Enzymatic, Glucose (Urinary, Non-Quantitative) |
CEN | Dye-Indicator, Ph (Urinary, Non-Quant.) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K061559 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
a064c57e-8046-4ac4-ab64-8e919c3eec46
April 20, 2023
7
November 04, 2016
April 20, 2023
7
November 04, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
00722066004371
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined