Clinical Diagnostic Solutions Inc

FDA Filings

This page includes the latest FDA filings for Clinical Diagnostic Solutions Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Clinical Diagnostic Solutions Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• BOULE MEDICAL AB

FDA Registration(s)

• Registration Number: 1064130
• FEI Number: 3002684533
• Name: CLINICAL DIAGNOSTIC SOLUTIONS, INC.
• Owner & Operator: Boule Diagnostics AB
• Contact Address: Domnarvsgatan 4 ; Spanga SE-NOTA SE-163 53 SE
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 1800 N.W. 65TH AVE. ; PLANTATION, FL 33313 US
• Establishment Type:
  • Manufacture Medical Device
  • Repack or Relabel Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
GUDID 00812137011848 CLINICAL DIAGNOSTIC SOLUTIONS, INC.	Albumin Reagent 501-397	2020-03-31
GUDID 00001812701208 CLINICAL DIAGNOSTIC SOLUTIONS, INC.	Triglycerides Reagent 501-417	2020-03-31
GUDID 00812137010261 CLINICAL DIAGNOSTIC SOLUTIONS, INC.	CDS-LTX PRIMER 502-007	2018-07-06
GUDID 00812137010254 CLINICAL DIAGNOSTIC SOLUTIONS, INC.	CDS-LTX CONTROL 502-006	2018-07-06
GUDID 00812137011947 CLINICAL DIAGNOSTIC SOLUTIONS, INC.	Carbon Dioxide Reagent 501-407	2018-06-11
GUDID 00812137011916 CLINICAL DIAGNOSTIC SOLUTIONS, INC.	Urea Nitrogen Reagent Set 501-404	2018-04-17
GUDID 00812137012203 CLINICAL DIAGNOSTIC SOLUTIONS, INC.	HbA1c Calibrator Set 502-189	2018-03-29
GUDID 00812137012197 CLINICAL DIAGNOSTIC SOLUTIONS, INC.	Multi-Analyte Lipid Control Set 502-160	2018-03-29
GUDID 00812137012173 CLINICAL DIAGNOSTIC SOLUTIONS, INC.	TIBC Calibrator Set 502-157	2018-03-29
GUDID 00812137012166 CLINICAL DIAGNOSTIC SOLUTIONS, INC.	HbA1c Control Set 502-156	2018-03-29
GUDID 00812137012159 CLINICAL DIAGNOSTIC SOLUTIONS, INC.	CRP Control Set 502-155	2018-03-29
GUDID 00812137012142 CLINICAL DIAGNOSTIC SOLUTIONS, INC.	CRP Calibrator Set 502-154	2018-03-29
GUDID 00812137012135 CLINICAL DIAGNOSTIC SOLUTIONS, INC.	Chemistry Control Level II Set 502-153	2018-03-29
GUDID 00812137012128 CLINICAL DIAGNOSTIC SOLUTIONS, INC.	Chemistry Control Level I Set 502-152	2018-03-29
GUDID 00812137012111 CLINICAL DIAGNOSTIC SOLUTIONS, INC.	Chemistry Calibrator Set 502-151	2018-03-29
GUDID 00812137012104 CLINICAL DIAGNOSTIC SOLUTIONS, INC.	Direct TIBC Reagent Set 501-444	2018-03-29
GUDID 00812137012098 CLINICAL DIAGNOSTIC SOLUTIONS, INC.	CRP Reagent Set 501-435	2018-03-29
GUDID 00812137012081 CLINICAL DIAGNOSTIC SOLUTIONS, INC.	HbA1c Reagent Set 501-421	2018-03-29
GUDID 00812137012074 CLINICAL DIAGNOSTIC SOLUTIONS, INC.	LDL Cholesterol Reagent Set 501-420	2018-03-29
GUDID 00812137012067 CLINICAL DIAGNOSTIC SOLUTIONS, INC.	HDL Cholesterol Reagent Set 501-419	2018-03-29
GUDID 00812137012050 CLINICAL DIAGNOSTIC SOLUTIONS, INC.	Uric Acid Reagent 501-418	2018-03-29
GUDID 00812137012036 CLINICAL DIAGNOSTIC SOLUTIONS, INC.	Total Protein Reagent 501-416	2018-03-29
GUDID 00812137012029 CLINICAL DIAGNOSTIC SOLUTIONS, INC.	Phosphorus Reagent 501-415	2018-03-29
GUDID 00812137012012 CLINICAL DIAGNOSTIC SOLUTIONS, INC.	Magnesium Reagent Set 501-414	2018-03-29
GUDID 00812137012005 CLINICAL DIAGNOSTIC SOLUTIONS, INC.	LDH Reagent Set 501-413	2018-03-29
GUDID 00812137011992 CLINICAL DIAGNOSTIC SOLUTIONS, INC.	Iron Reagent Set 501-412	2018-03-29
GUDID 00812137011985 CLINICAL DIAGNOSTIC SOLUTIONS, INC.	Glucose Reagent 501-411	2018-03-29
GUDID 00812137011978 CLINICAL DIAGNOSTIC SOLUTIONS, INC.	GGT Reagent Set 501-410	2018-03-29
GUDID 00812137011961 CLINICAL DIAGNOSTIC SOLUTIONS, INC.	Creatinine Reagent Set 501-409	2018-03-29
GUDID 00812137011954 CLINICAL DIAGNOSTIC SOLUTIONS, INC.	CK-NAC Reagent Set 501-408	2018-03-29
GUDID 00812137011930 CLINICAL DIAGNOSTIC SOLUTIONS, INC.	Cholesterol Reagent 501-406	2018-03-29
GUDID 00812137011923 CLINICAL DIAGNOSTIC SOLUTIONS, INC.	Calcium Arsenazo III Reagent 501-405	2018-03-29
GUDID 00812137011909 CLINICAL DIAGNOSTIC SOLUTIONS, INC.	Total Bilirubin Reagent Set 501-403	2018-03-29
GUDID 00812137011893 CLINICAL DIAGNOSTIC SOLUTIONS, INC.	Direct Bilirubin Reagent Set 501-402	2018-03-29
GUDID 00812137011886 CLINICAL DIAGNOSTIC SOLUTIONS, INC.	AST (SGOT) Reagent Set 501-401	2018-03-29
GUDID 00812137011879 CLINICAL DIAGNOSTIC SOLUTIONS, INC.	AMYLASE (CNPG3) Reagent Set 501-400	2018-03-29
GUDID 00812137011862 CLINICAL DIAGNOSTIC SOLUTIONS, INC.	ALT (SGPT) Reagent Set 501-399	2018-03-29
GUDID 00812137011855 CLINICAL DIAGNOSTIC SOLUTIONS, INC.	Alkaline Phosphatase Reagent Set 501-398	2018-03-29
GUDID 00812137011299 CLINICAL DIAGNOSTIC SOLUTIONS, INC.	Boule Con-Diff Tri-Level 501-608	2018-03-29
GUDID 00812137010421 CLINICAL DIAGNOSTIC SOLUTIONS, INC.	CDS Hematology Calibrator 502-068	2018-03-29
GUDID 00812137010414 CLINICAL DIAGNOSTIC SOLUTIONS, INC.	CDS 3PD Hematology Control 502-066	2018-03-29
GUDID 00812137010360 CLINICAL DIAGNOSTIC SOLUTIONS, INC.	CDS Hematology Calibrator 502-040	2018-03-29
GUDID 00812137010247 CLINICAL DIAGNOSTIC SOLUTIONS, INC.	CDS™ 3-PD Hematology Control 502-004	2018-03-29
GUDID 00812137010230 CLINICAL DIAGNOSTIC SOLUTIONS, INC.	Boule Con-Diff Tri-Level 501-607	2018-03-29
GUDID 00812137010223 CLINICAL DIAGNOSTIC SOLUTIONS, INC.	Boule Cal 501-606	2018-03-29
GUDID 00812137010216 CLINICAL DIAGNOSTIC SOLUTIONS, INC.	Boule Con-Diff Tri-Level 501-605	2018-03-29
GUDID 00081213701184 CLINICAL DIAGNOSTIC SOLUTIONS, INC.	Albumin Reagent 501-397	2018-03-29
JCB CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	Cell-Dyn Emerald Cleaner	2015-11-17
JCB CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	501-350 Quintus 5-Part Stopper	2015-11-17
JCB CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	501-293 Quintus 5-Part Stopper	2015-11-17
JCB CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	501-205 CDS Rinse Solution	2015-11-17
JCB CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	501-204 CDS Rinse Solution	2015-11-17
JCB CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	501-074 Enzymatic Cleaner Concentrate	2015-11-17
JCB CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	501-073 CDS DETERGENT REAGENT	2015-11-17
JCB CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	501-066 CDS DETERGENT REAGENT	2015-11-17
JCB CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	501-064 CDS DETERGENT REAGENT	2015-11-17
JCB CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	501-063 ENZYMATIC CLEANER CONCENTRATE	2015-11-17
JCB CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	501-036 Boule Cleaning Kit	2015-11-17
JCB CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	501-032 ENZYMATIC CLEANER	2015-11-17
JCB CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	501-029 Ac.T Cleaner and Shutdown Solution	2015-11-17
JCB CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	501-013 Enzymatic Cleaner Concentrate	2015-11-17
JCB CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	501-002 ENZYMATIC CLEANER	2015-11-17
PPM CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	501-515 Swelab Alfa Combo Pack	2013-02-13
PPM CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	501-222 Medonic M-Series DualPack	2013-02-13
PPM CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	501-028 Ac T Diff Reagent Pack	2013-02-13
PPM CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	501-009 CDS 5-PD Reagent Set	2013-02-13
GIF CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	Cell-Dyn Emerald Diluent	2013-02-13
GIF CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	501-504 Medonic CA 620/530 Diluent	2013-02-13
GIF CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	501-292 Quintus 5-Part Diluent	2013-02-13
GIF CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	501-287 CDS Abacus 3 Diluent	2013-02-13
GIF CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	501-212 Medonic M-Series Diluent	2013-02-13
GIF CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	501-208 Swelab Alfa Diluent	2013-02-13
GIF CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	501-202 CDS Hematology Diluent	2013-02-13
GIF CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	501-201 CDS Hematology Diluent	2013-02-13
GIF CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	501-133 CDS KX21 Hematology Diluent	2013-02-13
GIF CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	501-128 HEMATOLOGY DILUENT	2013-02-13
GIF CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	501-081 CDS Diluent Sheath	2013-02-13
GIF CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	501-069 CDS HEMATOLOGY DILUENT	2013-02-13
GIF CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	501-067 CDS HEMATOLOGY DILUENT	2013-02-13
GIF CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	501-057 CDS Hematology Diluent	2013-02-13
GIF CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	501-056 CDS Hematology Diluent	2013-02-13
GIF CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	501-052 CDS Hematology Diluent	2013-02-13
GIF CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	501-003 HEMATOLOGY DILUENT	2013-02-13
PMN K993375 | KSA CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	502-007 CDS-LTX Primer	2011-10-11
PMN K993375 | KSA CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	502-006 CDS-LTX Control	2011-10-11
PMN K993375 | KRZ CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	502-007 CDS-LTX Primer	2011-10-11
PMN K993375 | KRZ CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	502-006 CDS-LTX Control	2011-10-11
PMN K993375 | KRY CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	502-007 CDS-LTX Primer	2011-10-11
PMN K993375 | KRY CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	502-006 CDS-LTX Control	2011-10-11
PMN K993375 | KRX CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	502-007 CDS-LTX Primer	2011-10-11
PMN K993375 | KRX CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	502-006 CDS-LTX Control	2011-10-11
PMN K041130 CLINICAL DIAGNOSTIC SOLUTIONS, INC.	CDS HEMATOLOGY CALIBRATOR (CDS CAL)	2004-06-10
PMN K024173 CLINICAL DIAGNOSTIC SOLUTIONS, INC.	CDS 3-PD HEMATOLOGY CONTROLS	2003-01-14
PMN K993375 CLINICAL DIAGNOSTIC SOLUTIONS, INC.	CDS LTX CONTROL LATEX PARTICLE SUSPENSION AND PRIMER	1999-12-20
GJH CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	STAIN	1999-11-02
GJH CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	RETICULOCYTE	1999-11-02
KIP CLINICAL DIAGNOSTIC SOLUTIONS, INC. [Boule Diagnostics AB]	501-050 CDS SHEATH REAGENT	1999-04-08

Related Finance Registrations

NCAGE Code	1LXY2	CLINICAL DIAGNOSTIC SOLUTIONS INC.
CAGE Code	1LXY2	CLINICAL DIAGNOSTIC SOLUTIONS INC.
DUNS	048144997	CLINICAL DIAGNOSTIC SOLUTIONS, INC.

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020052314878	Anvers,Belgium -> Charleston, South Carolina	BOTTLE, CLEANING KIT	4 PKG
2020041717913	Shanghai ,China (Mainland) -> Los Angeles, California	DODECYLTRIMETHYLAMMONIUM CHLORIDE	13 DRM
2020041142982	Shanghai ,China (Mainland) -> Los Angeles, California	DODECYLTRIMETHYLAMMONIUM CHLORIDE	13 DRM
2019121237239	Shanghai ,China (Mainland) -> Los Angeles, California	DODECYLTRIMETHYLAMMONIUM CHLORIDE	5 DRM
2019112346155	Stadersand,Federal Republic of Germany -> Charleston, South Carolina	CLEANING KIT	3 PKG
2019060331575	Anvers,Belgium -> Charleston, South Carolina	CLEANING KIT	4 PKG
2019031833171	Shanghai ,China (Mainland) -> Los Angeles, California	DODECYLTRIMETHYLAMMONIUM CHLORIDE	20 DRM
2018111644127	Shanghai ,China (Mainland) -> Los Angeles, California	DODECYLTRIMETHYLAMMONIUM CHLORIDE	10 DRM