Primary Device ID | 04048534002035 |
NIH Device Record Key | e295f6ab-3838-430a-a71b-1a84346d217c |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Hemo Control Hemoglobin Microcuvette |
Version Model Number | 3000-3012-0765 |
Catalog Number | 3000-3012-0765 |
Company DUNS | 330046442 |
Company Name | EKF-diagnostic GmbH |
Device Count | 50 |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 04048534000031 [Primary] |
GS1 | 04048534002035 [Unit of Use] |
GKR | System, Hemoglobin, Automated |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-05-18 |
Device Publish Date | 2021-05-10 |
04048534002165 - DiaSpect Tm | 2022-10-25 For the quantitative determination of hemoglobin in whole blood. |
04048534002011 - EKF Link | 2021-10-25 EKF Link is a data and device management system that enables healthcare professionals to transfer, manage, store and display mea |
04048534002035 - Hemo Control Hemoglobin Microcuvette | 2021-05-18For the quantitative determination of hemoglobin in whole blood. |
04048534002035 - Hemo Control Hemoglobin Microcuvette | 2021-05-18 For the quantitative determination of hemoglobin in whole blood. |
04048534002028 - Hemo Control | 2021-05-18 For the quantitative determination of hemoglobin in whole blood. |
04048534002004 - DiaSpect Control HBT4 | 2021-03-22 For the verification of the precision and accuracy of DiaSpect Tm and DiaSpect Tm Cuvettes |
04048534001977 - DiaSpect Control HBT1 | 2021-03-22 For the verification of the precision and accuracy of DiaSpect Tm and DiaSpect Tm Cuvettes |
04048534001984 - DiaSpect Control HBT2 | 2021-03-22 For the verification of the precision and accuracy of DiaSpect Tm and DiaSpect Tm Cuvettes |
04048534001991 - DiaSpect Control HBT3 | 2021-03-22 For the verification of the precision and accuracy of DiaSpect Tm and DiaSpect Tm Cuvettes |