Primary Device ID | 00894175000817 |
NIH Device Record Key | 91e87796-4c23-4587-8d9a-70f2b2094134 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | AccuDiag ™ |
Version Model Number | DACD2095-18 |
Catalog Number | 2095-18 |
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 | 8185913030 |
OneStep@rapidtest.com | |
Phone | 8185913030 |
OneStep@rapidtest.com | |
Phone | 8185913030 |
OneStep@rapidtest.com | |
Phone | 8185913030 |
OneStep@rapidtest.com | |
Phone | 8185913030 |
OneStep@rapidtest.com | |
Phone | 8185913030 |
OneStep@rapidtest.com | |
Phone | 8185913030 |
OneStep@rapidtest.com | |
Phone | 8185913030 |
OneStep@rapidtest.com | |
Phone | 8185913030 |
OneStep@rapidtest.com | |
Phone | 8185913030 |
OneStep@rapidtest.com | |
Phone | 8185913030 |
OneStep@rapidtest.com | |
Phone | 8185913030 |
OneStep@rapidtest.com | |
Phone | 8185913030 |
OneStep@rapidtest.com | |
Phone | 8185913030 |
OneStep@rapidtest.com | |
Phone | 8185913030 |
OneStep@rapidtest.com | |
Phone | 8185913030 |
OneStep@rapidtest.com | |
Phone | 8185913030 |
OneStep@rapidtest.com | |
Phone | 8185913030 |
OneStep@rapidtest.com |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00894175000817 [Primary] |
CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-07-13 |
Device Publish Date | 2023-07-05 |
00894175000428 | AccuDiag ™ Gliadin IgG Multiple Coeliac disease-associated antibody IVD, kit, enzyme immunoass |
00894175000336 | AccuDiag ™ Rheumatoid factor IVD, kit, enzyme immunoassay (EIA) The Diagnostic Automation Rh |
00894175000237 | AccuDiag ™ dsDNA Double stranded DNA antibody (anti-dsDNA) IVD, kit, enzyme immunoassay (EIA |
00894175000220 | AccuDiag ™ SSB/La antibody (Sjogren's antibody) IVD, kit, enzyme immunoassay (EIA). A collect |
00894175000213 | AccuDiag ™ SSA/Ro antibody (Sjogren's antibody) IVD, kit, enzyme immunoassay (EIA) The SS-A Te |
00894175000008 | AccuDiag ™ IFA FTA-ABS Test System - Treponema pallidum total antibody IVD, kit, Fluorescent I |
00894175000404 | AccuDiag ™ ANCA Screen IgG ELISA Kit A collection of reagents and other associated materials |
00894175000060 | AccuDiag ™ Mumps IgM A collection of reagents and other associated materials intended to be us |
00894175000053 | AccuDiag ™ Cytomegalovirus (CMV) IgG is an enzyme-linked immunosorbent assay (ELISA) for the |
00894175000046 | AccuDiag ™ Herpes Simplex Virus (HSV) 1 & 2 IgM ELISA is an enzyme-linked immunosorbent assay |
00894175000039 | AccuDiag ™ Rubella IgG ELISA is designed for the qualitative and/or quantitative detection of |
00894175000022 | AccuDiag ™ Borrelia burgdorferi IgG/IgM is an enzyme-linked immunosorbent assay (ELISA) for th |
00894175000077 | AccuDiag ™ RPR Latex Test Kit A collection of reagents and other associated materials intended |
00894175000121 | AccuDiag ™ Strongyloides IgG ELISA The Strongyloides ELISA test is a qualitative enzyme immuno |
00894175000107 | AccuDiag ™ Toxocara IgG ELISA The Toxocara ELISA test is a qualitative enzyme immunoassay for |
00894175000923 | AccuDiag ™Free T4 ELISA kit is intended for the quantitative Determination of Free Thyroxine C |
00894175000893 | AccuDiag ™ T4 ELISA Kit For the quantitative determination of the Total Thyroxine (T4) concent |
00894175000886 | AccuDiag ™T3 ELISA is intended for the quantitative determination of Triiodothyronine (T3) con |
00894175000787 | AccuDiag ™ Estradiol ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic m |
00894175000749 | AccuDiag ™Mycoplasma pneumoniae IgM Test System provides a means for the qualitative detection |
00894175000565 | AccuDiag ™Digoxin ELISA -The Quantitative Determination of Digoxin Concentration in Human Seru |
00894175000015 | AccuDiag ™ Varicella-Zoster Virus (VZV) IgG Enzyme-linked Immunosorbent Assay (ELISA) is inten |
00850049545907 | AccuDiag ™ SLE Latex Test Kit is a latex slide agglutination assay for the qualitative and sem |
00850049545693 | AccuDiag ™ Rubella IgM Enzyme- Linked Immunosorbent Assay (ELISA) is intended for the in vitro |
00850049545686 | AccuDiag ™Rubella IgG Enzyme- Linked Immunosorbent Assay (ELISA) is intended for the in vitro |
00850049545662 | AccuDiag ™Toxoplasma (Toxo) IgG Enzyme-Linked Immunosorbent Assay (ELISA) is intended for the |
00850049545396 | AccuDiag ™Measles IgG Enzyme-Linked Immu-nosorbent Assay (ELISA) is intended for the detection |
00850054026095 | AccuDiag ™ Herpes Simplex 1 IgG (HSV 1 IgG) ELISA |
00850054026088 | AccuDiag ™Herpes Simplex 2 IgG (HSV 2 IgG) ELISA |
00894175000817 | AccuDiag ™Testeosterone ELISA Kit |
00894175000763 | AccuDiag ™Free Testosterone ELISA is intended for the quantitative measurement of free testost |
00850049545242 | AccuDiag ™ Cortisol ELISA kit is intended for the Quantitative determination of Total Cortiso |
00894175000831 | AccuDiag™ Ascaris IgG ELISA For the qualitative detection of immunoglobulin G (IgG) antibodies |
00894175000626 | AccuDiag™ Trichinella IgG ELISA - For the qualitative detection of immunoglobulin G (IgG) anti |
00894175000299 | AccuDiag™ Taenia.solium (Cysticercosis) IgG ELISA -For the qualitative and/or quantitative det |
00894175000282 | AccuDiag™ Fasciola IgG ELISA |
00894175000114 | AccuDiag™ Schistosoma IgG ELISA - For the qualitative detection of immunoglobulin G (IgG) anti |
00850049545259 | AccuDiag™ Borrelia VlsE1pepC10 IgG/IgM ELISA A collection of reagents and other associated mat |
00850049545211 | AccuDiag™ Leptospira IgM ELISA - |
00894175000138 | AccuDiag™ Echinococcus IgG ELISA |
00850054026262 | AccuDiag™ TSH Ultra-Sensitive ELISA |
00850049545235 | AccuDiag ™ H. pylori Antigen ELISA Intended to be used for the qualitative and/or quantitative |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ACCUDIAG 85042566 4091726 Live/Registered |
Diagnostic Automation, Inc. 2010-05-19 |