Primary Device ID | 04987481100992 |
NIH Device Record Key | 11e94047-ff69-4c22-a0a9-4c63f9d554bb |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | NEFA Standard Solution |
Version Model Number | 276-76491 |
Catalog Number | 276-76491 |
Company DUNS | 690598875 |
Company Name | FUJIFILM WAKO PURE CHEMICAL CORPORATION |
Device Count | 4 |
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 |
Phone | 781-323-5300 |
fmsuregulatoryaffairs@fujifilm.com | |
Phone | 781-323-5300 |
fmsuregulatoryaffairs@fujifilm.com | |
Phone | 781-323-5300 |
fmsuregulatoryaffairs@fujifilm.com | |
Phone | 781-323-5300 |
fmsuregulatoryaffairs@fujifilm.com | |
Phone | 781-323-5300 |
fmsuregulatoryaffairs@fujifilm.com | |
Phone | 781-323-5300 |
fmsuregulatoryaffairs@fujifilm.com | |
Phone | 781-323-5300 |
fmsuregulatoryaffairs@fujifilm.com | |
Phone | 781-323-5300 |
fmsuregulatoryaffairs@fujifilm.com | |
Phone | 781-323-5300 |
fmsuregulatoryaffairs@fujifilm.com | |
Phone | 781-323-5300 |
fmsuregulatoryaffairs@fujifilm.com | |
Phone | 781-323-5300 |
fmsuregulatoryaffairs@fujifilm.com | |
Phone | 781-323-5300 |
fmsuregulatoryaffairs@fujifilm.com | |
Phone | 781-323-5300 |
fmsuregulatoryaffairs@fujifilm.com | |
Phone | 781-323-5300 |
fmsuregulatoryaffairs@fujifilm.com |
Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 04987481100992 [Unit of Use] |
GS1 | 10856626006011 [Previous] |
GS1 | 14987481100999 [Primary] |
JIT | Calibrator, Secondary |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-11-02 |
Device Publish Date | 2020-10-23 |
10856626006011 | In-Vitro Diagnostic Use |
04987481100992 | In-Vitro Diagnostic Use |