| Primary Device ID | 00812117016207 |
| NIH Device Record Key | 514b8430-5292-4a9a-b5bf-12271e4df997 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FluoroQuench Acridine Orange/Ethidium Bromide - 2000 ml |
| Version Model Number | N/A |
| Catalog Number | FQAE2000 |
| Company DUNS | 118289289 |
| Company Name | ONE LAMBDA, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 | 800.822.8824 |
| 1lambda-TechSupport@thermofisher.com | |
| Phone | 800.822.8824 |
| 1lambda-TechSupport@thermofisher.com |
| Storage Environment Temperature | Between 2 Degrees Celsius and 5 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 5 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00812117016207 [Primary] |
| KQC | Stains, Hematology |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-07-02 |
| Device Publish Date | 2018-05-31 |
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| 00812117014654 - LABScreen™ Single Antigen HLA Class II ExPlex | 2020-06-11 LABScreen products are intended for use in detection of HLA antibody using flow cytometric technology |
| 00814695022496 - UniMatch™ Plus Software | 2019-01-23 UniMatch PLUS Software analyzes the reaction patterns of UniTray™ and AllSet+™ Gold kits for the determination of Human Leuk |
| 00812117015255 - Adsorb Out | 2018-07-16 To reduce high background that is caused by nonspecific binding of materials in human sera to the latex beads used in flow antib |
| 00814695024452 - Micro SSP™ Gel System - 108 Wells | 2018-07-16 The Micro SSP Gel Box System is a compact gel box for electrophoresis. |
| 00812117015873 - Fluorobeads™ T Lymphocyte – 25 Isolations | 2018-07-02 FluoroBeads-T provide a simple procedure for the isolation of T lymphocytes for use in microcytotoxicity assays using fluorescen |
| 00812117015880 - Fluorobeads™ B Lymphocyte – 25 Isolations | 2018-07-02 FluoroBeads-B provide a simple procedure for the isolation of B lymphocytes for use in HLA Class II typing assays using fluoresc |