Synermed® IR056-1200

GUDID 05060500091989

HDL-Cholesterol Reagent 2 X 66 mL + 1 X 44 mL

INFRARED LABORATORY SYSTEMS LLC

Low density lipoprotein (LDL) cholesterol IVD, reagent

• Primary Device ID: 05060500091989
• NIH Device Record Key: 25d0c016-4cfd-4384-8399-a50c168c3e4a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Synermed®
• Version Model Number: IR056-1200
• Catalog Number: IR056-1200
• Company DUNS: 014210494
• Company Name: INFRARED LABORATORY SYSTEMS LLC
• 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: true
• Device Combination Product: false
• Single Use: false
• 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

Customer Support Contacts

• Phone: 317 896-1565
• Email: info@irlabsystems.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 4 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060500091989 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072395

FDA Product Code

• 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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-02-28

On-Brand Devices [Synermed®]

• 05060500092030: Multi-Analyte DAU Control Kit 4 X 15 mL
• 05060500092023: Multi-Analyte DAU Calibrator Kit 4 X 15 mL
• 05060500092016: Sodium Reagent 2 X 66 mL + 1 X 66 mL
• 05060500092009: Potassium Reagent 2 X 66 mL + 1 X 33 mL
• 05060500091996: LDL-Cholesterol Reagent 2 X 66 mL + 1 X 44 mL
• 05060500091989: HDL-Cholesterol Reagent 2 X 66 mL + 1 X 44 mL
• 05060500091972: Uric Acid Reagent 2 X 67 mL + 1 X 54 mL
• 05060500091965: UIBC Reagent 2 X 66 mL + 2 X 1 mL + 1 X 44 mL
• 05060500091958: Triglycerides Reagent 8 X 67 mL + 8 wedges
• 05060500091941: Total Protein Reagent 6 X 67 mL + 3 X 67 mL
• 05060500091934: Phosphorus Reagent 2 X 67 mL + 1 X 54 mL
• 05060500091927: Magnesium Reagent 4 X 67 mL
• 05060500091910: LDH Reagent 2 X 67 mL + 1 X 54 mL
• 05060500091903: Serum Iron Reagent 2 X 67 mL + 1 X 44 mL
• 05060500091897: Glucose Reagent 6 X 67 mL + 3 X 54 mL
• 05060500091880: GGT Reagent 3 X 67 mL + 3 wedges
• 05060500091873: Creatinine Reagent 4 X 67 mL + 4 X 67 mL
• 05060500091866: Creatine Kinase Reagent 2 X 60 mL + 1 X 60 mL + 3 wedges
• 05060500091859: Cholesterol Reagent 6 X 67 mL + 3 X 54 mL
• 05060500091842: Chloride Reagent 3 X 67 mL
• 05060500091835: Calcium Reagent 8 X 67 mL
• 05060500091828: Total Bilirubin Reagent 8 X 67 mL
• 05060500091811: Direct Bilirubin Reagent 2 X 67 mL
• 05060500091804: Urea Nitrogen (BUN) Reagent 6 X 500 mL
• 05060500091798: Urea Nitrogen (BUN) Enzyme Reagent 6 X 500 mL
• 05060500091781: Urea Nitrogen (BUN) Coenzyme Reagent 6 X 500 mL
• 05060500091774: Urea Nitrogen (BUN) Reagent 6 X 50 mL + 3 X 50 mL
• 05060500091767: Urea Nitrogen (BUN) Reagent 4 X 25 mL + 4 X 12.5 mL
• 05060500091750: Urea Nitrogen (BUN) Reagent 1 X 200 mL + 1 X 100 mL
• 05060500091743: Urea Nitrogen (BUN) Reagent 3 X 200 mL + 3 X 100 mL
• 05060500091736: Urea Nitrogen (BUN) Reagent 6 X 67 mL + 3 X 67 mL
• 05060500091729: AST Reagent 8 X 67 mL + 2 X 67 mL
• 05060500091712: ALT Reagent 8 X 67 mL + 2 X 67 mL
• 05060500091705: Amylase Reagent 2 X 67 mL
• 05060500091699: AMP Alkaline Phosphatase Reagent 6 X 67mL + 6 powder wedges
• 05060500091682: Albumin Reagent 8 X 67 mL
• 05060500091675: Drugs of Abuse Level 2 Control 1 X 15 mL
• 05060500091668: Drugs of Abuse Level 1 Control 1 X 15 mL
• 05060500091651: Drugs of Abuse High Calibrator 1 X 15 mL
• 05060500091644: Drugs of Abuse Intermediate Calibrator 1 X 15 mL
• 05060500091637: Drugs of Abuse Cutoff Calibrator 1 X 15 mL
• 05060500091620: Drugs of Abuse Low Calibrator 1 X 15 mL
• 05060500091613: Drugs of Abuse Negative Calibrator 1 X 15 mL
• 05060500091606: Alcohol Standards and Controls 6 X 25 mL
• 05060500091590: ISE Calibrators and Controls 12 X 15 mL
• 05060500091576: CO2 Controls 12 X 15 mL
• 05060500091569: CO2 Calibrators 12 X 15 mL
• 05060500091552: Affirm 2 Multi Analyt High Control 12 X 5 mL (reconstituted)
• 05060500091545: Affirm 1 Multi Analyt Low Control 12 X 5 mL (reconstituted)
• 05060500091538: IRCal II Multi Analyt Calibrator 12 X 5 mL (reconstituted)