| Primary Device ID | 06971674866909 | 
| NIH Device Record Key | 0f636792-a62b-46de-b99b-faf3778fce49 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | BIOBASE | 
| Version Model Number | R1:50mL×2 R2:10mL×2 | 
| Company DUNS | 420046355 | 
| Company Name | Biobase Biodustry(Shandong)Co., Ltd. | 
| 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 | 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 | 06971674866909 [Primary] | 
| JGF | Differential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2023-08-01 | 
| Device Publish Date | 2023-07-24 | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  BIOBASE  90556153  not registered Live/Pending | Innovasis, Inc. 2021-03-02 | 
|  BIOBASE  88777188  not registered Live/Pending | Greenberry Eco-Industries, LLC 2020-01-29 | 
|  BIOBASE  87769317  not registered Dead/Abandoned | Omex Agrifluids, Inc. 2018-01-24 | 
|  BIOBASE  86772518  5098399 Live/Registered | BIOBUS, INC. 2015-09-29 | 
|  BIOBASE  86407168  not registered Dead/Abandoned | NuSmile, Ltd. 2014-09-26 | 
|  BIOBASE  86105370  4676788 Live/Registered | Greenberry Eco-Industries, LLC 2013-10-30 | 
|  BIOBASE  85098045  4018259 Dead/Cancelled | A. SCHULMAN, INC. 2010-08-02 | 
|  BIOBASE  79367647  not registered Live/Pending | GAN YI WU 2022-12-05 | 
|  BIOBASE  79241390  5853835 Live/Registered | BioBeats Group Limited 2018-06-26 | 
|  BIOBASE  79122498  4412774 Live/Registered | GAN YI WU 2012-07-18 | 
|  BIOBASE  79120714  not registered Dead/Abandoned | Clariant AG 2012-08-22 | 
|  BIOBASE  78880987  3438167 Dead/Cancelled | Privaris, Inc. 2006-05-10 |