| Primary Device ID | 04987486001959 |
| NIH Device Record Key | fb1202f6-6985-4a4d-9eda-826a28ef36b4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | S.G. Calibrator H |
| Version Model Number | 100672 |
| Company DUNS | 008171162 |
| Company Name | ARKRAY USA, INC. |
| 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 | 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 |
| Phone | 9999999999 |
| xxx@xxx.xxx | |
| Phone | 9999999999 |
| xxx@xxx.xxx | |
| Phone | 9999999999 |
| xxx@xxx.xxx | |
| Phone | 9999999999 |
| xxx@xxx.xxx | |
| Phone | 9999999999 |
| xxx@xxx.xxx | |
| Phone | 9999999999 |
| xxx@xxx.xxx | |
| Phone | 9999999999 |
| xxx@xxx.xxx | |
| Phone | 9999999999 |
| xxx@xxx.xxx | |
| Phone | 9999999999 |
| xxx@xxx.xxx | |
| Phone | 9999999999 |
| xxx@xxx.xxx | |
| Phone | 9999999999 |
| xxx@xxx.xxx | |
| Phone | 9999999999 |
| xxx@xxx.xxx | |
| Phone | 9999999999 |
| xxx@xxx.xxx | |
| Phone | 9999999999 |
| xxx@xxx.xxx | |
| Phone | 9999999999 |
| xxx@xxx.xxx |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 04987486001959 [Primary] |
| JMT | Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) |
| 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 | 2017-04-12 |
| 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 | 2024-05-31 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 |