m2000 9K15-01
GUDID 00884999031814
m2000rt Instrument System
ABBOTT MOLECULAR INC.
Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated| Primary Device ID | 00884999031814 |
| NIH Device Record Key | 03dfdcc8-8f45-4a83-b59c-d4f4284ec86c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | m2000 |
| Version Model Number | 9K15-01 |
| Catalog Number | 9K15-01 |
| Company DUNS | 878263359 |
| Company Name | ABBOTT MOLECULAR 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 | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| 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
Operating and Storage Conditions
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00884999031814 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K092705
FDA Product Code
| OOI | real time Nucleic acid amplification system |
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 | 2016-09-01 |
On-Brand Devices [m2000]
| 30884999046482 | Master Mix Tubes |
| 30884999046475 | 5mL Reaction Vessels |
| 30884999046451 | 1000ul Pipette Tips |
| 30884999046444 | 200ul Pipette Tips |
| 00884999043503 | m2000rt SYSTEM SOFTWARE Release 8.0 |
| 00884999043497 | m2000sp SYSTEM SOFTWARE, Release 8.0 |
| 00884999032064 | Adhesive Cover Applicator |
| 00884999032057 | Splash Free Support Base |
| 00884999031814 | m2000rt Instrument System |
| 00884999031753 | m2000sp Instrument E-Series |
| 00884999006911 | STRIPRACK 16MM TUBES |
| 00884999006898 | STRIPRACK 13MM TUBES |
| 00884999006577 | Abbott m2000rt Optical Calibration Kit |
| 00884999006539 | Optical Adhesive Cover |
| 00884999006522 | 96-Well Optical Reaction Plate |
| 00884999006515 | 200 mL Reagent Vessels |
| 00884999006492 | Biohazard Bags |
| 00884999006485 | 96 Deep-Well Plates |
| 00884999003668 | Proteinase K, Recombinant, PCR Grade |
| 00884999002883 | Hood Assembly G-Series |
| 00884999001381 | m2000 System Pierceable Cap Sample Rack Set |
| 00884999001350 | m2000 System 16mm PoSt Set |
| 00884999001343 | m2000 System 13mm PoSt Set |
| 00884999001336 | m2000 System Pierceable Cap Sample Rack PoSt Set |
| 00884999000414 | Reagent Vessel Carrier Assembly |
| 20884999046478 | 5mL Reaction Vessels |
| 20884999046454 | 1000ul Pipette Tips |
| 20884999046447 | 200ul Pipette Tips |
| 20884999046485 | Master Mix Tubes |
Trademark Results [m2000]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 M2000 78910562 not registered Dead/Abandoned |
First Lady International Corp. 2006-06-16 |
 M2000 76166444 2565173 Dead/Cancelled |
Snell Memorial Foundation, Inc. 2000-11-16 |
 M2000 74262591 not registered Dead/Abandoned |
Talkomatic Corporation 1992-04-06 |
 M2000 74063884 1779704 Dead/Cancelled |
M2000 COMERCIO E REPRESENTACOES LTDA. 1990-05-25 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.