Question 1

What type of products does ClearChem Diagnostics Inc. manufacture?

Accepted Answer

ClearChem Diagnostics Inc. specializes in the production of in vitro diagnostic reagents designed for clinical chemistry testing. Their portfolio includes a wide range of assays used to measure substances such as bilirubin, Vitamin D, C-reactive protein, glucose, creatinine, cholesterol, triglycerides, and various enzymes like alkaline phosphatase, aspartate aminotransferase, and alanine aminotransferase.

Question 2

Where is ClearChem Diagnostics Inc. located?

Accepted Answer

ClearChem Diagnostics Inc. is based in the United States. This location serves as the primary base for their operations in manufacturing in vitro diagnostic reagents for clinical chemistry applications.

Question 3

How are the medical devices from ClearChem Diagnostics Inc. classified?

Accepted Answer

The medical devices produced by ClearChem Diagnostics Inc. are classified as either Class I or Class II devices. These classifications are used to categorize the regulatory requirements for the various in vitro diagnostic reagents the company manufactures for clinical chemistry testing.

Question 4

Where can I find regulatory information regarding the devices produced by ClearChem Diagnostics Inc.?

Accepted Answer

The devices manufactured by ClearChem Diagnostics Inc. are listed in the FDA UDI database. This database is used for the regulatory tracking and identification of medical devices, ensuring that each product is properly documented according to regulatory standards.

Device	Model / Reference	Registries	Class	Status
ClearChem Diagnostics Inc. Glucose	GLU1140	FDA UDI	Class II	Active
ClearChem Diagnostics Inc. Amylase	AMY1030	FDA UDI	Class II	Active
ClearChem Diagnostics Inc. Creatinine (Jaffe)	CRE1120	FDA UDI	Class II	Active
ClearChem Diagnostics Inc. Bilirubin, Total	BRB1060	FDA UDI	Class II	Active
ClearChem Diagnostics Inc. Alanine aminotransferase (ALT)	ALT1020	FDA UDI	Class I	Active
ClearChem Diagnostics Inc. Inorganic Phosphorous	PHO1300	FDA UDI	Class I	Active
ClearChem Diagnostics Inc. MicroAlbumin	MAL1010	FDA UDI	Class II	Active
ClearChem Diagnostics Inc. High-Density Lipoprotein (HDL) Cholesterol	HDL1210	FDA UDI	Class I	Active
ClearChem Diagnostics Inc. Total Bilirubin	BRB212	FDA UDI	Class II	Active
ClearChem Diagnostics Inc. Direct Bilirubin	BRD210	FDA UDI	Class II	Active
ClearChem Diagnostics Inc. Creatine Kinase (CK)	CPK1110	FDA UDI	Class II	Active
ClearChem Diagnostics Inc. Triglycerides	TRG1400	FDA UDI	Class I	Active
ClearChem Diagnostics Inc. Low-Density Lipoprotein (LDL) Cholesterol	LDL1230	FDA UDI	Class I	Active
ClearChem Diagnostics Inc. Vitamin D (25-OH-D) Set	VTD1200	FDA UDI	Class II	Active
ClearChem Diagnostics Inc. Calcium	CAL1080	FDA UDI	Class II	Active
ClearChem Diagnostics Inc. Cholesterol, Total	CHL1100	FDA UDI	Class I	Active
ClearChem Diagnostics Inc. MicroProtein, Total	MPN2020	FDA UDI	Class II	Active
ClearChem Diagnostics Inc. High Sensitivity C-Reactive Protein (hS-CRP)	CRP1320	FDA UDI	Class II	Active
ClearChem Diagnostics Inc. Gamma-glutamyltransferase (GGT)	GGT1130	FDA UDI	Class I	Active
ClearChem Diagnostics Inc. Magnesium	MAG1180	FDA UDI	Class I	Active
ClearChem Diagnostics Inc. Hemoglobin A-1c	HGB1200	FDA UDI	Class II	Active
ClearChem Diagnostics Inc. Lactate Dehydogenase (LDH)	LDH1170	FDA UDI	Class II	Active
ClearChem Diagnostics Inc. Blood Urea Nitrogen (BUN)	BUN1070	FDA UDI	Class II	Active
ClearChem Diagnostics Inc. Albumin	ALB1000	FDA UDI	Class II	Active
ClearChem Diagnostics Inc. Protein, Total	TPR1310	FDA UDI	Class II	Active
ClearChem Diagnostics Inc. Aspartate aminotransferase (AST)	AST1040	FDA UDI	Class II	Active
ClearChem Diagnostics Inc. TIBC-Direct	ITI1160	FDA UDI	Class I	Active
ClearChem Diagnostics Inc. Uric Acid	URA1500	FDA UDI	Class I	Active
ClearChem Diagnostics Inc. Vitamin D (25-OH-D) Kit	VTD1100	FDA UDI	Class II	Active
ClearChem Diagnostics Inc. Alkaline Phosphatase (ALP)	ALP1010	FDA UDI	Class II	Active
ClearChem Diagnostics Inc. Iron	IRN1150	FDA UDI	Class I	Active
ClearChem Diagnostics Inc. Bilirubin, Direct	BRD1050	FDA UDI	Class II	Active
ClearChem Diagnostics Inc. Carbon Dioxide (CO2)	CAR1090	FDA UDI	Class II	Active

CLEARCHEM DIAGNOSTICS INC.

What CLEARCHEM DIAGNOSTICS INC. makes

Frequently asked questions

Information

Catalogue (33)

Related Companies

Authorised Representatives

Importers

Notified Bodies

Authorities