Primary Device ID | 00817273020150 |
NIH Device Record Key | a99a59df-44d9-430a-b00c-cf1983d1724a |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Diamedix |
Version Model Number | 720-320 |
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 | true |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | false |
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 |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00817273020150 [Primary] |
LFZ | Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2016-09-20 |
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 |