DEVICE: Tanner Scientific® (00850011007143)
Device Identifier (DI) Information
Tanner Scientific®
TNR 10SG
In Commercial Distribution
TNR 10SG
MERCEDES MEDICAL, LLC
TNR 10SG
In Commercial Distribution
TNR 10SG
MERCEDES MEDICAL, LLC
Tanner Scientific 10SG, 100/BTL, CLIA WAIVED, Tests for: Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, Leukocyte Esterase
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| Yes | |
| No | |
| No | |
| No | |
| No | |
| 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? |
|---|---|---|---|---|
| 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.
|
Active | false |
| 54521 | Urine nitrite 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 nitrites 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.
|
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.
|
Active | false |
| 54526 | Urine sediment IVD, reagent |
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or semi-quantitative screening of urine sediment.
|
Active | false |
| 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.
|
Active | false |
| 54524 | Urine specific gravity 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 specific gravity 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.
|
Active | false |
| 54527 | Urine urobilinogen 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 urobilinogen 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.
|
Active | false |
| 54525 | Urine sediment IVD, kit, spectrophotometry |
A collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative screening of urine sediment using a spectrophotometry method.
|
Active | false |
| 54520 | Urine leukocyte 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 leukocytes 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.
|
Active | false |
| 54517 | Urine creatinine 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 creatinine 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.
|
Active | false |
| 54514 | Multiple urine analyte IVD, kit, rapid colorimetric, clinical |
A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of urine for multiple analytes 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 screen for non-microbial markers associated with a urinary tract infection (UTI) [e.g., leukocytes, blood, nitrites, proteins]. It is not intended to be used for self-testing.
|
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.
|
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.
|
Active | false |
| 54516 | Urine bilirubin 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 bilirubin 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.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| LJX | Test, Urine Leukocyte |
| JMT | Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) |
| JMA | Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) |
| JJB | Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) |
| 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.) |
| CDM | Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) |
| JIO | Blood, Occult, Colorimetric, In Urine |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Special Storage Condition, Specify: Strips must be kept in the original bottle, or it may shorten the expiration date of product. |
| Special Storage Condition, Specify: Do not remove desiccants in the bottles. |
| Special Storage Condition, Specify: Keep away from direct sunlight, and moisture. |
| Handling Environment Temperature: between 39 and 86 Degrees Fahrenheit |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
5c0f001f-c048-4b0f-bd49-f89eb245b0cd
November 28, 2022
7
August 15, 2016
November 28, 2022
7
August 15, 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 |
|---|---|---|---|---|---|
| 10850011007140 | 100 | 00850011007143 | In Commercial Distribution | Inner pack | |
| 20850011007147 | 1 | 10850011007140 | In Commercial Distribution | Case |
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
8003312716
sherry.harris@mercedesmedical.com
sherry.harris@mercedesmedical.com