| Primary Device ID | 00850049545921 |
| NIH Device Record Key | 10b92d80-ffff-4a42-aac5-75ec49eca416 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | InstaTest |
| Version Model Number | DACDURS-1P (100) |
| Catalog Number | URS-1P(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 | false |
| OTC Over-The-Counter | false |
| Phone | 818-591-3030 |
| Onestep@rapidtest.com | |
| Phone | 818-591-3030 |
| Onestep@rapidtest.com | |
| Phone | 818-591-3030 |
| Onestep@rapidtest.com | |
| Phone | 818-591-3030 |
| Onestep@rapidtest.com | |
| Phone | 818-591-3030 |
| Onestep@rapidtest.com | |
| Phone | 818-591-3030 |
| Onestep@rapidtest.com | |
| Phone | 818-591-3030 |
| Onestep@rapidtest.com | |
| Phone | 818-591-3030 |
| Onestep@rapidtest.com | |
| Phone | 818-591-3030 |
| Onestep@rapidtest.com | |
| Phone | 818-591-3030 |
| Onestep@rapidtest.com | |
| Phone | 818-591-3030 |
| Onestep@rapidtest.com | |
| Phone | 818-591-3030 |
| Onestep@rapidtest.com | |
| Phone | 818-591-3030 |
| Onestep@rapidtest.com | |
| Phone | 818-591-3030 |
| Onestep@rapidtest.com | |
| Phone | 818-591-3030 |
| Onestep@rapidtest.com | |
| Phone | 818-591-3030 |
| Onestep@rapidtest.com |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00850049545921 [Primary] |
| JIR | Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-22 |
| Device Publish Date | 2023-06-14 |
| 00850054026156 - QMedix™ | 2025-06-13 QMedix™ Measles IgG Enzyme-Linked Immunosorbent Assay (ELISA) is intended for the detection and quantitative determination of |
| 00850054026941 - QMedix™ | 2025-04-04 QMedix™RF Latex Test Kit: The product is a latex agglutination slide test for the qualitative and semi quantitative in vitro d |
| 00850049545044 - AccuDiag™ | 2024-11-22 AccuDiag™ TSH ELISA -A collection of reagents and other associated materials intended to be used for the quantitative measurem |
| 00850054026798 - QMedix™ | 2024-11-22 QMedix™ FTA-ABS (Syphilis) IFA Kit 10x10 wells A collection of reagents and other associated materials intended to be used for |
| 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 |
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 |