urinalysis strips

GUDID 06971257037177

Weihai Kangzheng Medical Equipment Technology Co., Ltd

Multiple urine analyte IVD, control
Primary Device ID06971257037177
NIH Device Record Key666f5650-46f4-41a4-a5e3-716da2ba9ef8
Commercial Distribution StatusIn Commercial Distribution
Brand Nameurinalysis strips
Version Model Number3T
Company DUNS554480344
Company NameWeihai Kangzheng Medical Equipment Technology Co., Ltd
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS106971257037177 [Primary]

FDA Product Code

LJXTest, Urine Leukocyte

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-07-01
Device Publish Date2024-06-22

Devices Manufactured by Weihai Kangzheng Medical Equipment Technology Co., Ltd

06971257033698 - Tape and bandage, adhesive, adjustable closing mechanism, OTC use2024-07-01
06971257033704 - Tape and bandage, adhesive, adjustable closing mechanism, OTC use2024-07-01 Used to provide binding force on wound dressings or limbs for binding and fixation purposes.
06971257033773 - Tape and bandage, adhesive, adjustable closing mechanism, OTC use2024-07-01
06971257033780 - Tape and bandage, adhesive, adjustable closing mechanism, OTC use2024-07-01 Used to provide binding force on wound dressings or limbs for binding and fixation purposes.
06971257033797 - Tape and bandage, adhesive, adjustable closing mechanism, OTC use2024-07-01 Used to provide binding force on wound dressings or limbs for binding and fixation purposes.
06971257033803 - Tape and bandage, adhesive, adjustable closing mechanism, OTC use2024-07-01 Used to provide binding force on wound dressings or limbs for binding and fixation purposes.
06971257033810 - Tape and bandage, adhesive, adjustable closing mechanism, OTC use2024-07-01 Used to provide binding force on wound dressings or limbs for binding and fixation purposes.
06971257033827 - Tape and bandage, adhesive, adjustable closing mechanism, OTC use2024-07-01 Used to provide binding force on wound dressings or limbs for binding and fixation purposes.

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.