Primary Device ID | 05060500090944 |
NIH Device Record Key | a9f4b370-ec89-4eaa-953a-9d51d34db1f1 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Synermed® |
Version Model Number | IR070-WK |
Catalog Number | IR070-WK |
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 |
Phone | 317 896-1565 |
info@irlabsystems.com |
Storage Environment Temperature | Between 0 Degrees Celsius and 4 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 05060500090944 [Primary] |
CGA | Glucose Oxidase, Glucose |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2016-09-20 |
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) |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() SYNERMED 76061017 2613951 Dead/Cancelled |
GARDINER-CALDWELL SYNERMED 2000-06-01 |
![]() SYNERMED 75981730 3090541 Dead/Cancelled |
Ascend Media Medical and Healthcare, LLC 2000-06-01 |
![]() SYNERMED 75524287 2270762 Live/Registered |
ASCEND MEDIA MEDICAL AND HEALTHCARE, LLC 1998-07-23 |
![]() SYNERMED 74801663 1855188 Dead/Cancelled |
SYNERMED COMMUNICATIONS 1992-01-13 |
![]() SYNERMED 74595572 1931459 Live/Registered |
ASCEND MEDIA MEDICAL AND HEALTHCARE, LLC 1994-11-07 |
![]() SYNERMED 74371179 1915939 Live/Registered |
INFRARED LABORATORY SYSTEMS LLC 1993-03-23 |
![]() SYNERMED 74236973 not registered Dead/Abandoned |
SynerMed, Inc. 1992-01-13 |