ClearChem Diagnostics Inc. Low-Density Lipoprotein (LDL) Cholesterol LDL1230

GUDID 00852169008201

In Vitro Diagnostics testing kit R1:3X45mL, R2:3X15mL

CLEARCHEM DIAGNOSTICS INC.

Low density lipoprotein (LDL) cholesterol IVD, reagent Low density lipoprotein (LDL) cholesterol IVD, reagent

• Primary Device ID: 00852169008201
• NIH Device Record Key: b2a975e6-6285-498b-9d10-8eca6935bcb5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ClearChem Diagnostics Inc. Low-Density Lipoprotein (LDL) Cholesterol
• Version Model Number: LDL1230
• Catalog Number: LDL1230
• Company DUNS: 010655581
• Company Name: CLEARCHEM DIAGNOSTICS INC.
• Device Count: 1
• DM Exempt: true
• 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: 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(714)734-8041
• Email: dwheat@clearchem.net
• Phone: +1(714)734-8041
• Email: dwheat@clearchem.net

Device Dimensions

• Total Volume: 180 Milliliter
• Total Volume: 180 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Refrigerated
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852169008201 [Primary]

FDA Product Code

• LBR: Ldl & Vldl Precipitation, Hdl
• LBS: LDL & VLDL PRECIPITATION, CHOLESTEROL VIA ESTERASE-OXIDASE, HDL

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-05-12
• Device Publish Date: 2018-05-18

Devices Manufactured by CLEARCHEM DIAGNOSTICS INC.

• 00852169008201 - ClearChem Diagnostics Inc. Low-Density Lipoprotein (LDL) Cholesterol: 2020-05-12In Vitro Diagnostics testing kit R1:3X45mL, R2:3X15mL
• 00852169008201 - ClearChem Diagnostics Inc. Low-Density Lipoprotein (LDL) Cholesterol: 2020-05-12 In Vitro Diagnostics testing kit R1:3X45mL, R2:3X15mL
• 00852169008294 - ClearChem Diagnostics Inc. MicroProtein, Total: 2018-07-09 In Vitro Diagnostics testing kit R1:4X60mL, STD 1X15mL
• 00852169008232 - ClearChem Diagnostics Inc. TIBC-Direct: 2018-06-22 In Vitro Diagnostics testing kit R1:3X30mL, R2:3X18mL
• 00852169008270 - ClearChem Diagnostics Inc. MicroAlbumin: 2018-06-22 In Vitro Diagnostics testing kit R1:4X20mL, R2:2X10mL
• 00852169008287 - ClearChem Diagnostics Inc. Hemoglobin A-1c: 2018-06-22 In Vitro Diagnostics testing kit Buffer:1X36mL, R1a:1X16mL, R2b:1X6.7mL, R2:1X10.1mL
• 00852169008058 - ClearChem Diagnostics Inc. Aspartate aminotransferase (AST): 2018-06-18 In Vitro Diagnostics testing kit R1:3X60mL, R2:3X15mL
• 00852169008164 - ClearChem Diagnostics Inc. High-Density Lipoprotein (HDL) Cholesterol: 2018-06-18 In Vitro Diagnostics testing kit R1:3X45mL, R2:3X15mL
• 00852169008072 - ClearChem Diagnostics Inc. Carbon Dioxide (CO2): 2018-06-11 In Vitro Diagnostics testing kit R1:6X30mL