| Primary Device ID | M5255526950 |
| NIH Device Record Key | 0df149a4-2bab-4b76-b1fb-c86c5a73b98b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SPIFE Nexus IFE-9 Gel Kit |
| Version Model Number | 552695 |
| Company DUNS | 079396131 |
| Company Name | HELENA LABORATORIES CORPORATION |
| 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 | 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 |
| Phone | +1(800)231-5663 |
| helena@helena.com | |
| Phone | +1(800)231-5663 |
| helena@helena.com | |
| Phone | +1(800)231-5663 |
| helena@helena.com | |
| Phone | +1(800)231-5663 |
| helena@helena.com | |
| Phone | +1(800)231-5663 |
| helena@helena.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M5255526950 [Primary] |
| CFF | Immunoelectrophoretic, Immunoglobulins, (G, A, M) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-06-03 |
| Device Publish Date | 2022-05-26 |
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| M52594200 - IFE IgE Antiserum | 2024-10-07 |
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| M52518360 - V8 Urine Preparation Buffer | 2023-09-18 |
| M5255526930 - SPIFE Nexus Split Beta SPE - 80, 100 Gel Kit | 2023-09-18 |
| M52510680010 - SPIFE Touch, CSA 2015 (120V) | 2023-09-11 |