Primary Device ID | M5255526930 |
NIH Device Record Key | 9d52ef68-3a69-475e-a857-141df70abb72 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | SPIFE Nexus Split Beta SPE - 80, 100 Gel Kit |
Version Model Number | 552693 |
Company DUNS | 079396131 |
Company Name | HELENA LABORATORIES CORPORATION |
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 | 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 | |
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 | |
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 | M5255526930 [Primary] |
CEF | Electrophoretic, Protein Fractionation |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-09-18 |
Device Publish Date | 2023-09-08 |
M52518360 - V8 Urine Preparation Buffer | 2023-09-18 |
M5255526930 - SPIFE Nexus Split Beta SPE - 80, 100 Gel Kit | 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 |
M52510690000 - SPIFE Touch (230V) | 2023-09-11 |
M52510880010 - SPIFE 3000 w/ New Pump & Valve (110V) | 2023-09-11 |
M52510880020 - SPIFE 3000, "CE 2011" (120V) | 2023-09-11 |
M52510890010 - SPIFE 3000 w/ New Pump & Valve (220V) | 2023-09-11 |
M52510890020 - SPIFE 3000, "CE 2011" (230V) | 2023-09-11 |