STATSENSOR 43922
GUDID 00385480439220
StatSensor Creat Control Level 2
NOVA BIOMEDICAL CORPORATION
Creatinine IVD, control| Primary Device ID | 00385480439220 |
| NIH Device Record Key | 1129024b-306b-44e5-a72f-751a4c2bd20e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | STATSENSOR |
| Version Model Number | 1.0 |
| Catalog Number | 43922 |
| Company DUNS | 070617139 |
| Company Name | NOVA BIOMEDICAL CORPORATION |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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(180)054-5668 |
| info@novabio.com | |
| Phone | +1(180)054-5668 |
| info@novabio.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00385480439220 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K070068
FDA Product Code
| JJX | Single (specified) analyte controls (assayed and unassayed) |
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 | 2016-09-20 |
On-Brand Devices [STATSENSOR]
| 10385480506684 | StatSensor Creatinine Meter with Battery and Quick Reference Guide |
| 10385480453353 | StatSensor Creatinine Meter with Quick Reference Guide - Remanufactured |
| 10385480440520 | StatSensor Creatinine Meter with Battery and Quick Reference Guide |
| 00385480440370 | StatSensor Creat Linearity Level 1 - 5 |
| 00385480439237 | StatSensor Creat Control Level 3 |
| 00385480439220 | StatSensor Creat Control Level 2 |
| 00385480439213 | StatSensor Creat Control Level 1 |
Trademark Results [STATSENSOR]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 STATSENSOR 77083580 3565121 Live/Registered |
NOVA BIOMEDICAL CORPORATION 2007-01-16 |
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