Primary Device ID | 80664369402552 |
NIH Device Record Key | 483df7b1-29ca-441f-b9b1-cc6704bd6311 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | pocH-pack D |
Version Model Number | PPD-300A |
Company DUNS | 690664461 |
Company Name | SYSMEX CORPORATION |
Device Count | 2 |
DM Exempt | false |
Pre-market Exempt | true |
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 | 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 | |
Phone | +1(888)879-7639 |
crc@sysmex.com | |
Phone | +1(888)879-7639 |
crc@sysmex.com | |
Phone | +1(888)879-7639 |
crc@sysmex.com | |
Phone | +1(888)879-7639 |
crc@sysmex.com | |
Phone | +1(888)879-7639 |
crc@sysmex.com | |
Phone | +1(888)879-7639 |
crc@sysmex.com | |
Phone | +1(888)879-7639 |
crc@sysmex.com | |
Phone | +1(888)879-7639 |
crc@sysmex.com | |
Phone | +1(888)879-7639 |
crc@sysmex.com | |
Phone | +1(888)879-7639 |
crc@sysmex.com | |
Phone | +1(888)879-7639 |
crc@sysmex.com | |
Phone | +1(888)879-7639 |
crc@sysmex.com | |
Phone | +1(888)879-7639 |
crc@sysmex.com | |
Phone | +1(888)879-7639 |
crc@sysmex.com | |
Phone | +1(888)879-7639 |
crc@sysmex.com | |
Phone | +1(888)879-7639 |
crc@sysmex.com | |
Phone | +1(888)879-7639 |
crc@sysmex.com | |
Phone | +1(888)879-7639 |
crc@sysmex.com | |
Phone | +1(888)879-7639 |
crc@sysmex.com | |
Phone | +1(888)879-7639 |
crc@sysmex.com |
Total Volume | 2 Liter |
Total Volume | 2 Liter |
Total Volume | 2 Liter |
Total Volume | 2 Liter |
Total Volume | 2 Liter |
Total Volume | 2 Liter |
Total Volume | 2 Liter |
Total Volume | 2 Liter |
Total Volume | 2 Liter |
Total Volume | 2 Liter |
Total Volume | 2 Liter |
Total Volume | 2 Liter |
Total Volume | 2 Liter |
Total Volume | 2 Liter |
Total Volume | 2 Liter |
Total Volume | 2 Liter |
Total Volume | 2 Liter |
Total Volume | 2 Liter |
Total Volume | 2 Liter |
Total Volume | 2 Liter |
Total Volume | 2 Liter |
Total Volume | 2 Liter |
Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 10664369402553 [Primary] |
GS1 | 80664369402552 [Unit of Use] |
GIF | Diluent, Blood Cell |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-11-14 |
Device Publish Date | 2022-11-04 |
04987562503131 - XQ-320 XQ-Series Automated Hematology Analyzer | 2024-06-03 The XQ-Series analyzer (XQ-320) is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic |
04987562020102 - CELLPACK | 2022-12-08 CELLPACK is a reagent for measuring the numbers and sizes of RBC and platelets by the hydro dynamic focusing (DC Detection). |
04987562020171 - CELLPACK | 2022-12-08 CELLPACK is a reagent for measuring the numbers and sizes of RBC and platelets by the hydro dynamic focusing (DC Detection). |
04987562022090 - STROMATOLYSER-3WP | 2022-12-08 STROMATOLYSER-3WP is a lysing reagent to eliminate red blood cells and cell stroma for use in accurate determination of WBC coun |
04987562022335 - STROMATOLYSER-FB | 2022-12-08 STROMATOLYSER-FB is a reagent for analyzing basophil counts and WBC counts by the flow cytometry method, using a semiconductor l |
04987562200269 - STROMATOLYSER-IM | 2022-12-08 STROMATOLYSER-IM is lyse reagent for the IMI channel of Sysmex Automated Hematology Analyzers. |
04987562201389 - STROMATOLYSER-4DS | 2022-12-08 STROMATOLYSER-4DS is to be used to stain the leukocytes in diluted and lysed blood samples for determination of the 4-part diffe |
04987562201402 - STROMATOLYSER-4DL | 2022-12-08 The STROMATOLYSER-4DL is a reagent that lyses RBC for determination of 4-part differential count, or 5-part differential count* |