| Primary Device ID | 10888234001775 |
| NIH Device Record Key | 9420f8f8-c276-42d7-abf2-2df4fed98c1b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Gamma LO-ION |
| Version Model Number | 0704610 |
| Catalog Number | 0704610 |
| 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 | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 1-855-466-8267 |
| tech_support@immucor.com | |
| Phone | 1-855-466-8267 |
| tech_support@immucor.com | |
| Phone | 1-855-466-8267 |
| tech_support@immucor.com | |
| Phone | 1-855-466-8267 |
| tech_support@immucor.com | |
| Phone | 1-855-466-8267 |
| tech_support@immucor.com | |
| Phone | 1-855-466-8267 |
| tech_support@immucor.com | |
| Phone | 1-855-466-8267 |
| tech_support@immucor.com | |
| Phone | 1-855-466-8267 |
| tech_support@immucor.com | |
| Phone | 1-855-466-8267 |
| tech_support@immucor.com | |
| Phone | 1-855-466-8267 |
| tech_support@immucor.com |
| Storage Environment Temperature | Between 1 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 10 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10888234001775 [Primary] |
| KSG | Media, Potentiating For In Vitro Diagnostic Use |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-09-12 |
| Device Publish Date | 2016-04-15 |
| 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. |