SPOTCHEM™ II BUN
GUDID 00015482771058
Strip description for the invitro quantitative determination of blood urea nitrogen in human plasma from whole blood samples
ARKRAY USA, INC.
Magnesium (Mg2+) IVD, kit, spectrophotometry| Primary Device ID | 00015482771058 |
| NIH Device Record Key | a4dca6d3-0b42-4b0c-b7bd-675528ea1aef |
| Commercial Distribution Discontinuation | 2024-05-30 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | SPOTCHEM™ II BUN |
| Version Model Number | 77105 |
| Company DUNS | 008171162 |
| Company Name | ARKRAY USA, INC. |
| Device Count | 25 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| 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(877)538-8872 |
| xxx@xxx.xxx | |
| Phone | +1(877)538-8872 |
| xxx@xxx.xxx | |
| Phone | +1(877)538-8872 |
| xxx@xxx.xxx | |
| Phone | +1(877)538-8872 |
| xxx@xxx.xxx | |
| Phone | +1(877)538-8872 |
| xxx@xxx.xxx | |
| Phone | +1(877)538-8872 |
| xxx@xxx.xxx | |
| Phone | +1(877)538-8872 |
| xxx@xxx.xxx | |
| Phone | +1(877)538-8872 |
| xxx@xxx.xxx | |
| Phone | +1(877)538-8872 |
| xxx@xxx.xxx | |
| Phone | +1(877)538-8872 |
| xxx@xxx.xxx | |
| Phone | +1(877)538-8872 |
| xxx@xxx.xxx | |
| Phone | +1(877)538-8872 |
| xxx@xxx.xxx | |
| Phone | +1(877)538-8872 |
| xxx@xxx.xxx | |
| Phone | +1(877)538-8872 |
| xxx@xxx.xxx | |
| Phone | +1(877)538-8872 |
| xxx@xxx.xxx | |
| Phone | +1(877)538-8872 |
| xxx@xxx.xxx |
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 |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00015482771058 [Primary] |
| GS1 | 50015482771053 [Unit of Use] |
FDA Product Code
| JGJ | PHOTOMETRIC METHOD, MAGNESIUM |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2024-05-31 |
| Device Publish Date | 2016-09-23 |
Devices Manufactured by ARKRAY USA, INC.
| 00015482183103 - SPOTCHEM™ EZ Analyzer | 2024-05-31 Dry Chemistry Analyzer IVD, semi-automated |
| 00015482771010 - SPOTCHEM™ II Glucose | 2024-05-31 Strip description for the invitro quantitative determination of glucose in human plasma from whole blood samples |
| 00015482771027 - SPOTCHEM™ II Uric Acid | 2024-05-31 Strip description for the invitro quantitative determination of uric acid concentration in human plasma from whole blood samples |
| 00015482771034 - SPOTCHEM™ II Total Cholesterol | 2024-05-31 Strip description for the invitro quantitative determination of total cholesterol in human plasma from whole blood samples |
| 00015482771041 - SPOTCHEM™ II Triglycerides | 2024-05-31 Strip is for invitro quantitative determination of triglycerides in human plasma from whole blood samples |
| 00015482771058 - SPOTCHEM™ II BUN | 2024-05-31Strip description for the invitro quantitative determination of blood urea nitrogen in human plasma from whole blood samples |
| 00015482771058 - SPOTCHEM™ II BUN | 2024-05-31 Strip description for the invitro quantitative determination of blood urea nitrogen in human plasma from whole blood samples |
| 00015482771065 - SPOTCHEM™ II Total Bilirubin | 2024-05-31 Strip description for the invitro quantitative determination of total bilirubin concentration in human plasma from whole blood s |
| 00015482771072 - SPOTCHEM™ II Calcium | 2024-05-31 Strip description for the invitro quantitative determination of calcium concentration in human plasma from whole blood samples |
Trademark Results [SPOTCHEM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SPOTCHEM 79212401 5455851 Live/Registered |
ARKRAY, Inc. 2017-03-15 |
 SPOTCHEM 78239536 2910438 Live/Registered |
ARKRAY, INC. 2003-04-18 |
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