Primary Device ID | 00725609000182 |
NIH Device Record Key | ede6337a-fe66-4ab5-b14b-2ed02be49768 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | SPOTCHECK |
Version Model Number | 80-4065P10K |
Catalog Number | 80-4065P10K |
Company DUNS | 623238615 |
Company Name | ASTORIA-PACIFIC, 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 | false |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00725609000182 [Primary] |
KQP | Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase |
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 | 2016-10-14 |
00725609000519 | Incubation Bath, 110 Volt |
00725609000502 | Uridyltransferase Blank Cartridge |
00725609000496 | Uridyltransferase Active Cartridge |
00725609000458 | Negative Control Card |
00725609000441 | Positive Controls, Pkg/4 |
00725609000434 | NeoPac Software with Manual |
00725609000427 | 307 Detector, 3 Fluorometers |
00725609000410 | 307 Detector, 2 Fluorometers |
00725609000403 | 307 Detector, 1 Fluorometer |
00725609000397 | 315-2 Detector, 110 Volt with Tungsten |
00725609000380 | Uridyltransferase Blank Cartridge |
00725609000373 | Uridyltransferase Active Cartridge |
00725609000366 | Total Galactose + GALT Cartridge |
00725609000359 | Total Galactose Cartridge |
00725609000342 | G6PD Cartridge |
00725609000335 | Biotinidase Cartridge |
00725609000328 | 303A, 4 Heat Bath Cartridge Module |
00725609000311 | 303A, 3 Heat Bath Cartridge Module |
00725609000304 | 303A, 2 Heat Bath Cartridge Module |
00725609000298 | 303 Cartridge Base |
00725609000281 | Micropump 302D-EX,42 Position |
00725609000274 | 302D Micropump, 36 Position |
00725609000267 | SPOTCHECK Pro |
00725609000250 | Biotinidase PABA Stock Standard, 10 x 50 mL |
00725609000243 | Biotinidase System Control, 10 x 50 mL |
00725609000236 | Biotinidase System Control, 50 mL |
00725609000229 | Biotinidase PABA Stock Standard, 50 mL |
00725609000212 | Negative Controls, Pkg/4 |
00725609000205 | Positive Control Card |
00725609000182 | UT System Control, 10 x 50 mL |
00725609000175 | UT System Control, 50 mL |
00725609000168 | NADH Stock Standard, 10 x 50 mL |
00725609000151 | NADH Stock Standard, 50 mL |
00725609000144 | Biotinidase Microplate Reagent Kit, 60 Plate |
00725609000137 | Biotinidase Microplate Reagent Kit, 20 Plate |
00725609000120 | GALT Microplate Reagent Kit, 60 Plate |
00725609000113 | GALT Microplate Reagent Kit, 20 Plate |
00725609000106 | Total Galactose Microplate Reagent Kit, 60 Plate |
00725609000090 | Total Galactose Microplate Reagent Kit, 20 Plate |
00725609000083 | Biotinidase 50 Hour Reagent Kit |
00725609000076 | Biotinidase 50 Hour Reagent Kit |
00725609000069 | Uridyltransferase 50 Hour Reagent Kit |
00725609000052 | Uridyltransferase 50 Hour Reagent Kit |
00725609000045 | Uridyltransferase 50 Hour Reagent Kit |
00725609000038 | G6PD 25 Hour Reagent Kit |
00725609000021 | G6PD 50 Hour Reagent Kit |
00725609000014 | Total Galactose 50 Hour Reagent Kit |
00725609000007 | Phenylalanine 50 Hour Reagent Kit |
00725609000649 | T4 Neonatal Screening Kit, 480 Test; An Enzyme Immunoassay (EIA) for the Quantitative Determinat |
00725609000625 | 17-OHP Neonatal Screening Kit, 480 Test; An Enzyme Immunoassay (EIA) for the Quantitative Determ |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SPOTCHECK 98556294 not registered Live/Pending |
National Labs Inc. 2024-05-17 |
SPOTCHECK 90323842 not registered Live/Pending |
Knowledge Factor, Inc. 2020-11-17 |
SPOTCHECK 90071026 not registered Live/Pending |
Garcoa Inc 2020-07-24 |
SPOTCHECK 90021133 not registered Live/Pending |
iBucci Corp 2020-06-25 |
SPOTCHECK 88359644 not registered Live/Pending |
Ealing, Ryan Culver 2019-03-27 |
SPOTCHECK 85590418 4214059 Live/Registered |
Cobalt Digital, Inc. 2012-04-05 |
SPOTCHECK 85498528 4186356 Dead/Cancelled |
SpotCheck Applications, Inc. 2011-12-19 |
SPOTCHECK 85223509 4226413 Dead/Cancelled |
SPOTCHECK APPLICATIONS, INC. 2011-01-21 |
SPOTCHECK 85223505 4203027 Dead/Cancelled |
SPOTCHECK APPLICATIONS, INC. 2011-01-21 |
SPOTCHECK 78382019 3014077 Dead/Cancelled |
mVerify Corporation 2004-03-10 |
SPOTCHECK 78372850 3066688 Live/Registered |
FLUKE CORPORATION 2004-02-24 |
SPOTCHECK 77723733 3712022 Dead/Cancelled |
GARCOA, INC. 2009-04-28 |