Primary Device ID | 00811727010568 |
NIH Device Record Key | 3315ed86-013e-48d2-a8eb-67f723c300a9 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | POINTE SCIENTIFIC BUN (Berthelot) |
Version Model Number | B7551-120 |
Catalog Number | B7551-120 |
Company DUNS | 045623154 |
Company Name | POINTE SCIENTIFIC, 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 | 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@medtest.com | |
Phone | 800-445-9853 |
techservice@medtest.com |
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 | 00811727010568 [Primary] |
CDL | Berthelot Indophenol, Urea Nitrogen |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2016-08-31 |
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00811727015730 - Pointe AST on the BS480 Analyzer | 2023-07-06 Pointe AST packaged for use on the BS480 Analyzer. 5x60mL, 5x15mL Kit. For the quantitative determination of Aspartate Aminotran |
00811727015754 - Pointe Calcium Arsenazo for BS480 | 2023-07-06 Pointe Calcium Arsenazo packaged for the BS480 analyzer. 6x60mL Kit. For the quantitative determination of Calcium in serum or h |
00811727015778 - Pointe Cholesterol on BS480 | 2023-07-06 Pointe Cholesterol packaged to use on the BS480 Analyzer. 8x60mL Kit. For the quantitative determination of Total Cholesterol in |
00811727015792 - Pointe Carbon Dioxide on the BS480 | 2023-07-06 Pointe Carbon Dioxide packaged for use on the BS480 analyzer. 4x40mL Kit. For the quantitative determination of Carbon Dioxide |
00811727015839 - Pointe GGT on BS480 | 2023-07-06 Pointe GGT Reagent packaged for use on the BS480. 4x40mL 4x10mL Kit. For the quantitative kinetic determination of gamma glutamy |
00811727015846 - Pointe Glucose Hexokinase for BS480 | 2023-07-06 Pointe Glucose Hexokinase Reagent packaged for use on the BS480. 8x60 mL Kit. For the in vitro quantitative measurement of gluco |