Synermed® IR140-911

GUDID 05060500091415

Triglycerides Reagent 8 X 50 mL (reconstituted)

INFRARED LABORATORY SYSTEMS LLC

Glucose/ketone/lipid profile IVD, reagent
Primary Device ID05060500091415
NIH Device Record Key89740551-582e-4bf4-8384-b4488b90a041
Commercial Distribution StatusIn Commercial Distribution
Brand NameSynermed®
Version Model NumberIR140-911
Catalog NumberIR140-911
Company DUNS014210494
Company NameINFRARED LABORATORY SYSTEMS LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone317 896-1565
Emailinfo@irlabsystems.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 4 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105060500091415 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CDTLipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-20

On-Brand Devices [Synermed®]

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

Trademark Results [Synermed]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SYNERMED
SYNERMED
76061017 2613951 Dead/Cancelled
GARDINER-CALDWELL SYNERMED
2000-06-01
SYNERMED
SYNERMED
75981730 3090541 Dead/Cancelled
Ascend Media Medical and Healthcare, LLC
2000-06-01
SYNERMED
SYNERMED
75524287 2270762 Live/Registered
ASCEND MEDIA MEDICAL AND HEALTHCARE, LLC
1998-07-23
SYNERMED
SYNERMED
74801663 1855188 Dead/Cancelled
SYNERMED COMMUNICATIONS
1992-01-13
SYNERMED
SYNERMED
74595572 1931459 Live/Registered
ASCEND MEDIA MEDICAL AND HEALTHCARE, LLC
1994-11-07
SYNERMED
SYNERMED
74371179 1915939 Live/Registered
INFRARED LABORATORY SYSTEMS LLC
1993-03-23
SYNERMED
SYNERMED
74236973 not registered Dead/Abandoned
SynerMed, Inc.
1992-01-13

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