| Primary Device ID | 00817273020464 |
| NIH Device Record Key | 2fe1050e-f1b4-45cb-ae67-7914e50870ba |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Diamedix |
| Version Model Number | MAGO Plus |
| Company DUNS | 151765328 |
| Company Name | DIAMEDIX CORPORATION |
| 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 | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | 305-324-2300 |
| customerservice@erbadiagnostics.com | |
| Phone | 305-324-2300 |
| customerservice@erbadiagnostics.com | |
| Phone | 305-324-2300 |
| customerservice@erbadiagnostics.com |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817273020464 [Primary] |
| JJF | Analyzer, Chemistry, Micro, For Clinical Use |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-21 |
| 00817273020471 | Mago 4S Anayzer |
| 00817273020464 | MAGO Plus chemistry analyzer |
| 00817273020457 | "789-009 EZ Complement High Control" |
| 00817273020440 | "789-008 EZ Complement Low Control" |
| 00817273020433 | "789-006 EZ Complement Reference Serum" |
| 00817273020426 | "789-001 EZ Complement Cells" |
| 00817273020419 | "720-850 Mycoplasma IgG Test Kit" |
| 00817273020402 | "720-830 anti-β2 Glycoprotein I IgG/IgM Test Kit" |
| 00817273020396 | "720-790 ANA ELISA Screen Test Kit" |
| 00817273020389 | "720-710 Rheumatoid Factor Test Kit" |
| 00817273020372 | "720-700 anti-dsDNA Test Kit" |
| 00817273020365 | "720-650 EBV-EA-D IgM Test Kit" |
| 00817273020358 | "720-640 EBV-EA-D IgG Test Kit" |
| 00817273020341 | "720-630 EBNA-1 IgM Test Kit" |
| 00817273020334 | "720-620 EBNA-1 IgG Test Kit" |
| 00817273020327 | "720-610 EBV-VCA IgM Test Kit" |
| 00817273020310 | "720-600 EBV-VCA IgG Test Kit" |
| 00817273020303 | "720-540 Mumps IgG Test Kit" |
| 00817273020297 | "720-520 Measles IgG Test Kit" |
| 00817273020280 | "720-480 anti-Cardiolipin Screen" |
| 00817273020273 | "720-460 anti-TG IgG Test Kit" |
| 00817273020266 | "720-450 anti-TPO IgG Test Kit" |
| 00817273020259 | "720-440 anti-PR-3 (C-ANCA) IgG Test Kit" |
| 00817273020242 | "720-430 anti-MPO (P-ANCA) IgG Test Kit" |
| 00817273020235 | "720-420 anti-Cardiolipin IgATest Kit" |
| 00817273020228 | "720-400 anti-Cardiolipin IgG/IgM Test Kit" |
| 00817273020211 | "720-380 VZV IgG Test Kit" |
| 00817273020204 | "720-370 Rubella IgM Test Kit" |
| 00817273020198 | "720-360 Rubella IgG Test Kit" |
| 00817273020181 | "720-350 HSV 1&2 IgM Test Kit" |
| 00817273020174 | "720-340 HSV 1&2 IgG Test Kit" |
| 00817273020167 | "720-330 CMV IgM Test Kit" |
| 00817273020150 | "720-320 CMV IgG Test Kit" |
| 00817273020143 | "720-310 Toxoplasma IgM Test Kit" |
| 00817273020136 | "720-300 Toxoplasma IgG Test Kit" |
| 00817273020129 | "720-290 anti-Jo-1 Test Kit" |
| 00817273020112 | "720-280 anti-Scl-70 Test Kit" |
| 00817273020105 | "720-270 anti-SM/RNP Test Kit" |
| 00817273020099 | 720-260 anti-SSB Test Kit |
| 00817273020082 | 720-250 anti-SSA Test Kit |
| 00817273020075 | 720-240 anti-SM Test Kit |
| 00817273020068 | 720-230 ENA-6 Screen Test Kit |
| 00817273020051 | 720-130 H.pylori IgG Test Kit |
| 00817273020044 | "300-371A Rubella IgM Capture Lyoph. Ag. Accessory Kit" |
| 00817273020037 | 300-331A CMV IgM Capture Lyoph. Ag. Accessory Kit |
| 00817273020020 | "300-312A Toxoplasma IgM Capture Lyoph. Ag. Accessory Kit" |
| 00817273020013 | 251-035 ProbeClean Concentration Kit" |
| 00817273020006 | Calibration Test Kit |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() DIAMEDIX 74415947 1854431 Live/Registered |
Diamedix Corporation 1993-07-23 |