Primary Device ID | 00811727014214 |
NIH Device Record Key | de6b6250-6135-42d7-9eed-613688059300 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Pointe Scientific, Inc. Glucose Ox |
Version Model Number | 13-G7521-1000 |
Catalog Number | 13-G7521-1000 |
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 | 00811727014214 [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 | 2016-08-31 |
00811727014214 | Reagent for the quantitative determination of Glucose in serum. For in vitro diagnostic use onl |
00811727014207 | Reagent for the quantitative determination of Glucose in serum. For in vitro diagnostic use onl |
00811727014191 | Reagent for the quantitative determination of Glucose in serum. For in vitro diagnostic use onl |