Primary Device ID | 00811727015761 |
NIH Device Record Key | 29a9bc32-17f4-4639-bc58-84a3efa00886 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Pointe Creatinine Enzymatic on BS480 |
Version Model Number | 14-C7548-216 |
Catalog Number | 14-C7548-216 |
Company DUNS | 052845583 |
Company Name | HORIBA INSTRUMENTS INCORPORATED |
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 | 800-445-9853 |
techservice@medtestdx.com | |
Phone | 800-445-9853 |
techservice@medtestdx.com | |
Phone | 800-445-9853 |
techservice@medtestdx.com | |
Phone | 800-445-9853 |
techservice@medtestdx.com | |
Phone | 800-445-9853 |
techservice@medtestdx.com | |
Phone | 800-445-9853 |
techservice@medtestdx.com | |
Phone | 800-445-9853 |
techservice@medtestdx.com | |
Phone | 800-445-9853 |
techservice@medtestdx.com |
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 | 00811727015761 [Primary] |
JFY | Enzymatic Method, Creatinine |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2025-10-02 |
Device Publish Date | 2020-05-28 |
00811727015716 - Pointe ALT for the BS480 | 2025-10-02 Pointe ALT packaged for the BS480 Analyzer. 5x60mL, 5x15mL Kit. For the quantitative determination of Alanine Aminotransferase |
00811727015747 - Pointe BUN on BS480 | 2025-10-02 Pointe BUN packaged for use on the BS480 analyzer. 8x60mL, 8x15mL Kit. For the quantitative determination of urea nitrogen in se |
00811727015761 - Pointe Creatinine Enzymatic on BS480 | 2025-10-02Pointe Creatinine Enzymatic Reagent packaged for use on the BS480. 4x40mL, 4x14mL Kit. For the quantitative enzymatic determination of creatinine in serum and urine. For In Vitro Diagnostic Use Only. |
00811727015761 - Pointe Creatinine Enzymatic on BS480 | 2025-10-02 Pointe Creatinine Enzymatic Reagent packaged for use on the BS480. 4x40mL, 4x14mL Kit. For the quantitative enzymatic determinat |
00811727015785 - Pointe Creatine Kinase for BS480 | 2025-10-02 Pointe Creatine Kinase packaged for use on the BS480. 4x40mL, 4x15mL Kit. For the quantitative determination of creatine kinase |
00811727015808 - Pointe Creatinine for BS480 | 2025-10-02 Pointe Creatinine reagent packaged for use on the BS480 analyzer. 6x60mL, 6x12mL Kit. For the quantitative determination of crea |
00811727015822 - Pointe Direct Bilirubin for BS480 | 2025-10-02 Pointe Direct Bilirubin Reagent packaged for the BS480 analyzer. 4x40mL, 4x10mL Kit. For the quantitative determination of direc |
00811727015853 - Pointe HbA1c for the BS480 | 2025-10-02 Pointe HbA1c Reagent packaged for use on the BS480. 2x60mL, 2x20mL Kit. For the quantitative determination of Hemoglobin A1c (Hb |
00856605006004 - MINOCAL | 2018-03-29 Whole Blood Hematology Calibrator |