Primary Device ID | 00860006589783 |
NIH Device Record Key | 4e69e9ee-8d5d-4357-906f-118aadcc1d12 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ACCURUN® 2 Series 5600 |
Version Model Number | 2000-0100 |
Company DUNS | 106267123 |
Company Name | Lgc Clinical Diagnostics, 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 | true |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | true |
Manufacturing Date | true |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00860006589783 [Primary] |
JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-08-12 |
Device Publish Date | 2024-08-02 |
00850011135563 - VALIDATE | 2024-12-23 Validate LCMS Steroids Test Kit |
00850011135693 - AccuTrak | 2024-11-29 AccuTrak aTPO Calibration Verification Panel |
00850011135808 - Validate | 2024-11-29 Growth Hormone 2 Calibration Verification / Linearity Test Kit |
00850011135655 - AccuTrak | 2024-11-18 AccuTrak sFlt-1 Calibration Verification Panel |
00850011135761 - VALIDATE | 2024-10-28 VALIDATE MTX Calibration Verification / Linearity Test Kit |
00850011135730 - VALIDATE | 2024-10-17 Validate LCMS VIT D Test Kit |
00850011135723 - Validate | 2024-09-20 Validate THY Calibration Verification / Linearity Test Kit solutions are intended for in vitro diagnostic use in the determinati |
00850011135679 - VALIDATE | 2024-08-23 VALIDATE Fertility 4 Calibration Verification/Linearity Test Kit |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ACCURUN 90099182 not registered Live/Pending |
AccuRun LLC 2020-08-07 |
ACCURUN 75198245 2109153 Live/Registered |
SERACARE LIFE SCIENCES, INC. 1996-11-04 |