Primary Device ID | 10888234001010 |
NIH Device Record Key | 87029884-80ed-477a-a397-63ba7170f6a5 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | W.A.R.M. |
Version Model Number | 0057319 |
Catalog Number | 0057319 |
Company DUNS | 061446282 |
Company Name | IMMUCOR, INC. |
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 | 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 | 1-855-466-8267 |
tech_support@immucor.com |
Storage Environment Temperature | Between 1 Degrees Celsius and 10 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 10888234001010 [Primary] |
KSK | Solution, Stabilized Enzyme |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2016-04-18 |
10888234001546 - Capture-R Positive Control Serum (Weak), Capture-R Negative Control Serum | 2022-09-12 Immucor’s Capture-R Positive Control Serum (Weak) and Capture-R Negative Control Serum are run controls to be used in Capture- |
10888234001553 - Capture-R Select | 2022-09-12 The Capture-R Select Solid Phase System provides modified microwells for the immobilization of human erythrocytes for use in sol |
10888234001560 - Capture-P | 2022-09-12 Capture-P Solid Phase System is intended for use in the detection of antibodies to platelets. Capture-P Solid Phase System is de |
10888234001577 - Capture-P Positive Control Serum (Weak), Capture-P Negative Control Serum | 2022-09-12 Immucor’s Capture-P Positive Control Serum (Weak) and Capture-P Negative Control Serum are run controls to be used in the Capt |
10888234002291 - Capture LISS | 2022-09-12 Capture LISS is a low ionic solution containing glycine and the dye Bromocresol Purple and the preservative sodium azide (0.1%). |
10888234002307 - Capture-R Ready Indicator Red Cells | 2022-09-12 Anti-IgG-coated Indicator Red Cells for use in Capture-R Ready-Screen, Capture-R Ready-ID or Capture-R Select Solid Phase Assays |
10888234002314 - Capture-P Indicator Red Cells | 2022-09-12 Anti-IgG coated Indicator Red Cells are intended for use in Capture-P and Capture-P Ready-Screen solid phase assays for the dete |
10888234001522 - Referencells | 2022-08-11 Referencells (Pooled Cells) are intended for use in tube and microplate ABO serum grouping tests. |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
W.A.R.M. 73450163 not registered Dead/Abandoned |
COOPERBIOMEDICAL, INC. 1983-10-28 |