GENCHEM™ Alkaline Phosphatase GEN-ALP R1
GUDID 00851445007020
ALP REAG. 1 (BULK)
GENCHEM INC
Alkaline phosphatase (ALP) isoenzyme IVD, kit, enzyme spectrophotometry Alkaline phosphatase (ALP) isoenzyme IVD, kit, enzyme spectrophotometry Alkaline phosphatase (ALP) isoenzyme IVD, kit, enzyme spectrophotometry Alkaline phosphatase (ALP) isoenzyme IVD, kit, enzyme spectrophotometry Alkaline phosphatase (ALP) isoenzyme IVD, kit, enzyme spectrophotometry Alkaline phosphatase (ALP) isoenzyme IVD, kit, enzyme spectrophotometry Alkaline phosphatase (ALP) isoenzyme IVD, kit, enzyme spectrophotometry Alkaline phosphatase (ALP) isoenzyme IVD, kit, enzyme spectrophotometry Alkaline phosphatase (ALP) isoenzyme IVD, kit, enzyme spectrophotometry Alkaline phosphatase (ALP) isoenzyme IVD, kit, enzyme spectrophotometry Alkaline phosphatase (ALP) isoenzyme IVD, kit, enzyme spectrophotometry Alkaline phosphatase (ALP) isoenzyme IVD, kit, enzyme spectrophotometry Alkaline phosphatase (ALP) isoenzyme IVD, kit, enzyme spectrophotometry Alkaline phosphatase (ALP) isoenzyme IVD, kit, enzyme spectrophotometry Alkaline phosphatase (ALP) isoenzyme IVD, kit, enzyme spectrophotometry Alkaline phosphatase (ALP) isoenzyme IVD, kit, enzyme spectrophotometry Alkaline phosphatase (ALP) isoenzyme IVD, kit, enzyme spectrophotometry Alkaline phosphatase (ALP) isoenzyme IVD, kit, spectrophotometry Alkaline phosphatase (ALP) isoenzyme IVD, kit, spectrophotometry Alkaline phosphatase (ALP) isoenzyme IVD, kit, spectrophotometry Alkaline phosphatase (ALP) isoenzyme IVD, kit, spectrophotometry Alkaline phosphatase (ALP) isoenzyme IVD, kit, spectrophotometry Alkaline phosphatase (ALP) isoenzyme IVD, kit, spectrophotometry Alkaline phosphatase (ALP) isoenzyme IVD, kit, spectrophotometry Alkaline phosphatase (ALP) isoenzyme IVD, kit, spectrophotometry Alkaline phosphatase (ALP) isoenzyme IVD, kit, spectrophotometry Alkaline phosphatase (ALP) isoenzyme IVD, kit, spectrophotometry Alkaline phosphatase (ALP) isoenzyme IVD, kit, spectrophotometry Alkaline phosphatase (ALP) isoenzyme IVD, kit, spectrophotometry Alkaline phosphatase (ALP) isoenzyme IVD, kit, spectrophotometry Alkaline phosphatase (ALP) isoenzyme IVD, kit, spectrophotometry Alkaline phosphatase (ALP) isoenzyme IVD, kit, spectrophotometry| Primary Device ID | 00851445007020 |
| NIH Device Record Key | afc3b7e3-f19b-4674-ba0c-fbdb9dc22a5c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GENCHEM™ Alkaline Phosphatase |
| Version Model Number | GEN-ALP R1 |
| Catalog Number | GEN-ALP R1 |
| Company DUNS | 193856866 |
| Company Name | GENCHEM 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 | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(714)529-7125 |
| lorlow@genchem.org | |
| Phone | +1(714)529-7125 |
| lorlow@genchem.org | |
| Phone | +1(714)529-7125 |
| lorlow@genchem.org | |
| Phone | +1(714)529-7125 |
| lorlow@genchem.org | |
| Phone | +1(714)529-7125 |
| lorlow@genchem.org | |
| Phone | +1(714)529-7125 |
| lorlow@genchem.org | |
| Phone | +1(714)529-7125 |
| lorlow@genchem.org | |
| Phone | +1(714)529-7125 |
| lorlow@genchem.org | |
| Phone | +1(714)529-7125 |
| lorlow@genchem.org | |
| Phone | +1(714)529-7125 |
| lorlow@genchem.org | |
| Phone | +1(714)529-7125 |
| lorlow@genchem.org | |
| Phone | +1(714)529-7125 |
| lorlow@genchem.org | |
| Phone | +1(714)529-7125 |
| lorlow@genchem.org | |
| Phone | +1(714)529-7125 |
| lorlow@genchem.org | |
| Phone | +1(714)529-7125 |
| lorlow@genchem.org | |
| Phone | +1(714)529-7125 |
| lorlow@genchem.org | |
| Phone | +1(714)529-7125 |
| lorlow@genchem.org | |
| Phone | +1(714)529-7125 |
| lorlow@genchem.org | |
| Phone | +1(714)529-7125 |
| lorlow@genchem.org | |
| Phone | +1(714)529-7125 |
| lorlow@genchem.org | |
| Phone | +1(714)529-7125 |
| lorlow@genchem.org | |
| Phone | +1(714)529-7125 |
| lorlow@genchem.org | |
| Phone | +1(714)529-7125 |
| lorlow@genchem.org | |
| Phone | +1(714)529-7125 |
| lorlow@genchem.org | |
| Phone | +1(714)529-7125 |
| lorlow@genchem.org | |
| Phone | +1(714)529-7125 |
| lorlow@genchem.org | |
| Phone | +1(714)529-7125 |
| lorlow@genchem.org | |
| Phone | +1(714)529-7125 |
| lorlow@genchem.org | |
| Phone | +1(714)529-7125 |
| lorlow@genchem.org | |
| Phone | +1(714)529-7125 |
| lorlow@genchem.org | |
| Phone | +1(714)529-7125 |
| lorlow@genchem.org | |
| Phone | +1(714)529-7125 |
| lorlow@genchem.org |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00851445007020 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K964914
FDA Product Code
| CJE | NITROPHENYLPHOSPHATE, ALKALINE PHOSPHATASE OR ISOENZYMES |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-19 |
On-Brand Devices [GENCHEM™ Alkaline Phosphatase]
| 00851445007037 | ALP REAG. 2 (BULK) |
| 00851445007020 | ALP REAG. 1 (BULK) |
Trademark Results [GENCHEM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GENCHEM 76171200 not registered Dead/Abandoned |
Novasite Pharmaceuticals, Inc. 2000-11-22 |
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