InstaTest URS-2P (100)
GUDID 00894175000510
Diagnostic Automation Inc. URS-2P (100 Strips Bottle) for the semi-quantitative and qualitative detection of Glucose and Protein in Urine.
Diagnostic Automation, Inc.
Multiple urine analyte IVD, kit, colorimetric dipstick, rapid| Primary Device ID | 00894175000510 |
| NIH Device Record Key | 0b9169a1-4a09-48d1-a00f-f5b1832c955d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | InstaTest |
| Version Model Number | URS-2P (100) |
| Catalog Number | URS-2P (100) |
| Company DUNS | 878252071 |
| Company Name | Diagnostic Automation, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
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| Device Size Text, specify | 0 |
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| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Operating and Storage Conditions
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00894175000510 [Primary] |
FDA Product Code
| JIL | Method, Enzymatic, Glucose (Urinary, Non-Quantitative) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-10-01 |
| Device Publish Date | 2021-09-23 |
Devices Manufactured by Diagnostic Automation, Inc.
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| 00850054026729 - QMedix™ | 2024-11-06 QMedix™URS-10 InstaTest is intended to be used for the qualitative and/or (semi-)quantitative detection of urine for multiple |
| 00850054026781 - QMedix™ | 2024-11-06 QMedix™ URS-1P is intended semi-quantitative and qualitative detection of protein in urine. |
| 00850054026644 - QMedix™ | 2024-07-03 QMedix™ Herpes Simplex 1,2 IgM (HSV 1,2 IgM) ELISA is an enzyme-linked immunosorbent assay for the qualitative detection of Ig |
| 00850054026651 - QMedix™ | 2024-07-03 QMedix™ hCG Combo Urine/Serum RapiCard™ InstaTest is used for the qualitative and/or (semi-)quantitative detection of total |
| 00850049545235 - AccuDiag ™ | 2024-05-31 AccuDiag ™ H. pylori Antigen ELISA Intended to be used for the qualitative and/or quantitative detection of antigens from Heli |
| 00850054026613 - QMedix™ | 2024-05-31 QMedix™ EBV VCA IgG ImmunoFlourescent Assay |
Trademark Results [InstaTest]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 INSTATEST 79147000 not registered Dead/Abandoned |
LBC TECHNOLOGIES LIMITED 2014-03-13 |
 INSTATEST 79128287 not registered Dead/Abandoned |
LBC TECHNOLOGIES LIMITED 2012-10-31 |
 INSTATEST 79124706 not registered Dead/Abandoned |
LBC TECHNOLOGIES LIMITED 2012-07-03 |
 INSTATEST 78076520 not registered Dead/Abandoned |
Advanced Medical Systems, Inc. 2001-07-30 |
 INSTATEST 76200988 2698435 Live/Registered |
DIAGNOSTIC AUTOMATION, INC. 2001-01-29 |
 INSTATEST 74461474 2039594 Dead/Cancelled |
L. B. Couplings (Camden) Limited 1993-11-12 |
 INSTATEST 73186408 1127364 Dead/Cancelled |
CARTER-WALLACE, INC. 1978-09-21 |
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