k-assay.comK-ASSAY CRP (Ver.2)
Kamiya Biomedical Company, LLC
KAMIYA BIOMEDICAL COMPANY LLC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2084025 | 2084025 | KAMIYA BIOMEDICAL COMPANY LLC | 1 | Y | 2026-01-01 | 12779 Gateway Dr S Tukwila WA US 98168 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00816426020894 | K-ASSAY® Plasma Control - For use as a consistent test sample of known concentration for monitoring assay conditions for the listed constituents. | 206-575-8068 | diagnostics@k-assay.com |
| 00816426020924 | K-ASSAY® Coagulation Control - For use as a consistent test sample of known concentration for monitoring assay conditions for the listed constituents. | 206-575-8068 | diagnostics@k-assay.com |
| 00816426021013 | K-ASSAY® Coagulation Control - For use as a consistent test sample of known concentration for monitoring assay conditions for the listed constituents. | 206-575-8068 | diagnostics@k-assay.com |
| 00816426021099 | K-ASSAY® Factor XIII Control - For use as a consistent test sample of known concentration for monitoring assay conditions for Factor XIII. | 206-575-8068 | diagnostics@k-assay.com |
| 00816426021129 | K-ASSAY® Factor XIII Control - For use as a consistent test sample of known concentration for monitoring assay conditions for Factor XIII. | 206-575-8068 | diagnostics@k-assay.com |
| 00816426021266 | K-ASSAY® D-Dimer Control - For use as a consistent test sample of known concentration for monitoring assay conditions for D-Dimer. | 206-575-8068 | diagnostics@k-assay.com |
| 00816426021273 | K-ASSAY® D-Dimer Control - For use as a consistent test sample of known concentration for monitoring assay conditions for D-Dimer. | 206-575-8068 | diagnostics@k-assay.com |
| 00816426021600 | K-ASSAY® Cystatin C Calibrator - For the calibration of the K-ASSAY® Cystatin C assay. | 206-575-8068 | diagnostics@k-assay.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 42945 | 2003982042 | K993853 | K-ASSAY MULTI-ANALYTE CALIBRATOR | JIX | 1999-12-27 |
| 42945 | 1611286734 | K993606 | K-ASSAY APO A1/B CALIBRATOR SET | JIX | 1999-11-26 |
| 42945 | 1124950579 | K993537 | K-ASSAY TRANSFERRIN | DDG | 1999-11-30 |
| 42945 | 2042091755 | K993482 | K-ASSAY FIBRINOGEN | GIS | 1999-12-06 |
| 42945 | 1231333955 | K993481 | K-ASSAY C4 | DBI | 1999-11-29 |
| 42945 | 1646560455 | K993480 | K-ASSAY HAPTOGLOBIN | DAD | 1999-11-24 |
| 42945 | 1865282605 | K993444 | K-ASSAY ALPHA-1 AT | DEM | 1999-11-24 |
| 42945 | 1278764325 | K993441 | K-ASSAY ALPHA-1 AG | LKL | 1999-11-24 |
| 42945 | 1852339970 | K993437 | K-ASSAY C3 | CZW | 1999-11-24 |
| 42945 | 1259069101 | K993354 | K-ASSAY APO B | DER | 1999-10-28 |
| 42945 | 1318313047 | K993345 | K-ASSAY APO AI | DER | 1999-10-25 |
| 42945 | 2003807255 | K993323 | K-ASSAY IGM | CFF | 1999-11-30 |
| 42945 | 1599736960 | K993281 | K-ASSAY IGG | DEW | 1999-11-09 |
| 42945 | 1307872871 | K993213 | K-ASSAY IGA | CFF | 1999-11-23 |
| 42945 | 1005047851 | K991467 | K-ASSAY RHEUMATOID FACTOR CALIBRATOR SET | DHR | 1999-06-10 |
| 42945 | 1102234200 | K991409 | K-ASSAY RHEUMATOID FACTOR | DHR | 1999-06-09 |
| 42945 | 1724881690 | K991224 | K-ASSAY CRP | DCK | 1999-05-14 |
| 42945 | 1203841816 | K991210 | K-ASSAY CRP CALIBRATOR SET | DCK | 1999-05-11 |
| 42945 | 1656845550 | K983241 | ASO/CRP/RF CONTROLS FOR IMMUNOTURBIDIMETRIC ASSAYS | JJY | 1998-09-29 |
| 42945 | 1736266140 | K983130 | LIQUID IMMUNOLOGY CONTROLS FOR IMMUNOTURBIDIMETRIC ASSAYS | JJY | 1998-09-29 |
| 42945 | 1186801861 | K963085 | LIQUID IMMUNOLOGY CONTROL LEVEL I, II, III | JJX | 1996-08-20 |
| 42945 | 1406180233 | K831526 | URINE TOTAL PROTEIN CONTROL | JJW | 1983-08-12 |
| 42945 | 1291124528 | K242170 | K-ASSAY CRP (Ver.2) | DCK | 2025-04-18 |
| 42945 | 1969315135 | K192727 | K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2) | DHR | 2020-05-20 |
| 42945 | 1512106796 | K103557 | DIAZYME HS CRP ASSAY KIT / CALIBRATOR SET / CONTROL SET | DCK | 2011-04-27 |
| 42945 | 2045498288 | K093137 | K-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROL | NDY | 2010-09-28 |
| 42945 | 1330343666 | K091486 | K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATOR | DCF | 2010-04-29 |
| 42945 | 1102086749 | K050944 | K-ASSAY FERRITIN (2) & FERRITIN CALIBRATOR SET | DBF | 2005-12-23 |
| 42945 | 1075713249 | K042241 | K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093C | DGC | 2004-12-10 |
| 42945 | 1604351907 | K031539 | HEMOGLOBIN A1C REAGENT SET | LCP | 2003-08-06 |
| 42945 | 1108645946 | K030687 | K-ASSAY D-DIMER, K-ASSAY D-DIMER CALIBRATOR, MODELS KAI-090; KAJ-091C | DAP | 2003-06-27 |
| 42945 | 1980899659 | K023853 | K-ASSAY LP(A) CONTROLS | DFC | 2002-12-13 |
| 42945 | 2036683086 | K023828 | K-ASSAY C-REACTIVE PROTEIN (3), K-ASSAY CRP MULTI-CALIBRATOR D, K-ASSAY CRP MULTI-CALIBRATOR E, K-ASSAY CRP MULTI-CALIBR | DCK | 2003-02-04 |
| 42945 | 1565597552 | K022486 | K-ASSAY HS-CRP CONTROLS | DCK | 2002-08-14 |
| 42945 | 1592939419 | K021660 | K-ASSAY LP(A) ASSAY | DFC | 2002-07-25 |
| 42945 | 1044622107 | K012855 | LIQUISPX LIQUID LIPID CONTROL | JJY | 2001-08-30 |
| 42945 | 1830107823 | K011731 | TRI-POINT LIQUIMMUNE LIQUID ASSAYED CONTROL LEVELS 1,2, AND 3 | JJY | 2001-07-05 |
| 42945 | 1423161789 | K000679 | THROMBOSTRATE CONTROL PLASMAS | GGN | 2000-03-24 |
| 42945 | 1093375308 | ||||
| 42945 | 1238231405 | ||||
| 42945 | 1261700678 | ||||
| 42945 | 1285369057 | ||||
| 42945 | 1729625443 | ||||
| 42945 | 1735262073 | ||||
| 42945 | 1873852253 | ||||
| 42945 | 1903456303 | ||||
| 42945 | 1985503181 | ||||
| 42945 | 2018567374 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| DCK | 6 | 2025-04-18 |
| JJY | 4 | 2001-08-30 |
| DHR | 3 | 2020-05-20 |
| DFC | 2 | 2002-12-13 |
| JIX | 2 | 1999-12-27 |
| CFF | 2 | 1999-11-30 |
| DER | 2 | 1999-10-28 |
| NDY | 1 | 2010-09-28 |
| DCF | 1 | 2010-04-29 |
| DBF | 1 | 2005-12-23 |
| DGC | 1 | 2004-12-10 |
| LCP | 1 | 2003-08-06 |
| DAP | 1 | 2003-06-27 |
| GGN | 1 | 2000-03-24 |
| GIS | 1 | 1999-12-06 |
| DDG | 1 | 1999-11-30 |
| DBI | 1 | 1999-11-29 |
| CZW | 1 | 1999-11-24 |
| LKL | 1 | 1999-11-24 |
| DAD | 1 | 1999-11-24 |
| DEM | 1 | 1999-11-24 |
| DEW | 1 | 1999-11-09 |
| JJX | 1 | 1996-08-20 |
| JJW | 1 | 1983-08-12 |
PMN#
K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)
Kamiya Biomedical Company
K-ASSAY (R) FERRITIN REAGENT, K-ASSAY (R) FERRITIN CALIBRATOR
KAMIYA BIOMEDICAL COMPANY
GUDID#
K-ASSAY® Plasma Control - For use as a consistent test sample of known concentration for monitoring assay conditions for the listed constituents.
2016-09-16
K-ASSAY® Coagulation Control - For use as a consistent test sample of known concentration for monitoring assay conditions for the listed constituents.
2016-09-16
K-ASSAY® Coagulation Control - For use as a consistent test sample of known concentration for monitoring assay conditions for the listed constituents.
2016-09-16
K-ASSAY® Factor XIII Control - For use as a consistent test sample of known concentration for monitoring assay conditions for Factor XIII.
2017-02-09
K-ASSAY® Factor XIII Control - For use as a consistent test sample of known concentration for monitoring assay conditions for Factor XIII.
2017-02-09
K-ASSAY® D-Dimer Control - For use as a consistent test sample of known concentration for monitoring assay conditions for D-Dimer.
2018-05-30
K-ASSAY® D-Dimer Control - For use as a consistent test sample of known concentration for monitoring assay conditions for D-Dimer.
2018-05-30
K-ASSAY® Cystatin C Calibrator - For the calibration of the K-ASSAY® Cystatin C assay.
2026-04-16
K-ASSAY® Cystatin C Control - For use as a consistent test sample of known concentration for monitoring assay conditions for cystatin C.
2026-04-16
K-ASSAY® UIBC Reagent - For the quantitative determination of unsaturated iron binding capacity (UIBC) in serum.
2026-03-13
K-ASSAY® CRP Reagent (Ver.2) - For the quantitative determination of human C-reactive protein (CRP) in serum and plasma by immunoturbidimetric assay.
2026-02-27
K-ASSAY® CRP Calibrator (Ver.2) - For the calibration of the K-ASSAY® CRP (Ver.2) assay.
2026-02-27
K-ASSAY® Alpha-1 AG Reagent - For the quantitative determination of human alpha-1 acid glycoprotein (Alpha-1 AG) in serum by immunoturbidimetric assay.
2016-09-16
K-ASSAY® Total IgE Reagent - For the quantitative determination of human total IgE in serum or plasma by immunoturbidimetric assay.
2016-09-16
K-ASSAY® Total IgE Calibrator - For the calibration of the K-ASSAY® Total IgE assay.
2016-09-16
K-ASSAY® Total IgE Control - For use as a consistent test sample of known concentration for monitoring assay conditions for Total IgE.
2019-01-25
K-ASSAY® RF Calibrator (Ver.2) - For the calibration of the K-ASSAY® RF (Ver.2) assay
2024-04-17
K-ASSAY® CRP (3) Calibrator F - For the calibration of the K-ASSAY® CRP (3) assay.
2016-09-16
K-ASSAY® Fructosamine Reagent + Calibrator (L) - For the quantitative determination of fructosamine in serum.
2016-09-16
K-ASSAY® UIBC Reagent (L) - For the quantitative determination of unsaturated iron binding capacity (UIBC) in serum.
2019-04-09
K-ASSAY® Apo B Reagent (L) - For the quantitative determination of human apolipoprotein B (Apo B) in serum by immunoturbidimetric assay.
2016-09-16
K-ASSAY® CRP Reagent (L) - For the quantitative determination of human C-reactive protein (CRP) in serum by immunoturbidimetric assay.
2016-09-16
K-ASSAY® Fibrinogen Reagent (L) - For the quantitative determination of human fibrinogen in plasma.
2016-09-16
K-ASSAY® Transferrin Reagent (L) - For the quantitative determination of human transferrin in serum by immunoturbidimetric assay.
2016-09-16
K-ASSAY® Hemoglobin A1c Hemolysis Reagent - Hemolysis reagent for hemoglobin A1c (HbA1c) measurement.
2016-09-16
K-ASSAY® CRP (3) Calibrator D - For the calibration of the K-ASSAY® CRP (3) assay.
2018-02-23
K-ASSAY® Alpha-1 AT Reagent - For the quantitative determination of human alpha-1 anti-trypsin (Alpha-1 AT) in serum by immunoturbidimetric assay.
2016-09-16
K-ASSAY® Insulin Control - For use as a consistent test sample of known concentration for monitoring assay conditions for Insulin.
2019-01-25
K-ASSAY® Transferrin Reagent - For the quantitative determination of human transferrin in serum by immunoturbidimetric assay.
2016-09-16
K-ASSAY® Lp(a) Control - For use as a consistent test sample of known concentration for monitoring assay conditions for lipoprotein(a) [Lp(a)].
2016-09-16
K-ASSAY® Apo AI/B Calibrator - For the calibration of the K-ASSAY® Apo AI and Apo B assays.
2016-09-16
K-ASSAY® Liquid Lipid Control - For use as a consistent test sample of known concentration for monitoring assay conditions for the listed constituents.
2016-09-16
K-ASSAY® Beta-2 Microglobulin Reagent - For the quantitative determination of human beta-2 microglobulin in serum/plasma or urine by immunoturbidimetric assay.
2018-12-19
K-ASSAY® Beta-2 Microglobulin Serum / Plasma Calibrator - For the calibration of the K-ASSAY® Beta-2 Microglobulin assay.
2018-12-19
K-ASSAY® Beta-2 Microglobulin Urine Calibrator - For the calibration of the K-ASSAY® Beta-2 Microglobulin assay.
2018-12-19
K-ASSAY® Beta-2 Microglobulin / Ferritin - Serum / Plasma Control - For use as a consistent test sample of known concentration for monitoring assay conditions for beta-2 microglobulin.
2018-12-19
K-ASSAY® Beta-2 Microglobulin / Ferritin - Serum / Plasma Control - For use as a consistent test sample of known concentration for monitoring assay conditions for beta-2 microglobulin.
2018-12-19
K-ASSAY® Beta-2 Microglobulin Urine Control - For use as a consistent test sample of known concentration for monitoring assay conditions for beta-2 microglobulin.
2018-12-19
K-ASSAY® Beta-2 Microglobulin Urine Control - For use as a consistent test sample of known concentration for monitoring assay conditions for beta-2 microglobulin.
2018-12-19
K-ASSAY® Cystatin C Reagent - For the quantitative determination of human cystatin C in serum, EDTA plasma, or lithium heparin plasma by immunoturbidimetric assay.
2016-09-16