Primary Device ID | 14987562460585 |
NIH Device Record Key | fa0a0816-7b09-48ce-8211-11a818ba6808 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | X-CAL Calibrator |
Version Model Number | 110-4009-0 |
Company DUNS | 690664461 |
Company Name | SYSMEX 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 | true |
Device Combination Product | false |
Single Use | false |
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 | +1(888)879-7639 |
crc@sysmex.com | |
Phone | +1(888)879-7639 |
crc@sysmex.com |
Total Volume | 4.6 Milliliter |
Total Volume | 4.6 Milliliter |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 14987562460585 [Primary] |
KRX | CALIBRATOR FOR CELL INDICES |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2018-09-18 |
Device Publish Date | 2016-08-04 |
14987562460592 | X-Cal FSR Kit (5X4.6ML) |
14987562460585 | X-Cal Hematology Calibrator (4.6ML) |