Primary Device ID | 07070060014708 |
NIH Device Record Key | 2fa8df72-ad1d-4577-a4e1-74cadb88b864 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Afinion™ 2 |
Version Model Number | 1116986 |
Catalog Number | 1116986 |
Company DUNS | 515324122 |
Company Name | Abbott Diagnostics Technologies AS |
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 | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Handling Environment Temperature | Between 15 Degrees Celsius and 32 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between 15 Degrees Celsius and 32 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between 15 Degrees Celsius and 32 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between 15 Degrees Celsius and 32 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between 15 Degrees Celsius and 32 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between 15 Degrees Celsius and 32 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between 15 Degrees Celsius and 32 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between 15 Degrees Celsius and 32 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between 15 Degrees Celsius and 32 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between 15 Degrees Celsius and 32 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between 15 Degrees Celsius and 32 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between 15 Degrees Celsius and 32 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between 15 Degrees Celsius and 32 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between 15 Degrees Celsius and 32 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between 15 Degrees Celsius and 32 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between 15 Degrees Celsius and 32 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between 15 Degrees Celsius and 32 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between 15 Degrees Celsius and 32 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 07070060014708 [Primary] |
JQT | Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-11-03 |
Device Publish Date | 2023-10-26 |
07070060014708 | Afinion 2 is a compact, fully automated, multi-assay analyzer for professional near-patient test |
07070060014692 | Afinion 2 is a compact, fully automated, multi-assay analyzer for professional near-patient test |
07070060014623 | Afinion 2 is a compact, fully automated, multi-assay analyzer for professional near-patient test |
07070060014616 | Afinion 2 is a compact, fully automated, multi-assay analyzer for professional near-patient test |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
AFINION 76544018 2991061 Live/Registered |
ALERE TECHNOLOGIES AS 2003-09-11 |