H.PYLORI AM880-5M

GUDID 00810119671875

Multiple gastrointestinal disease marker IVD, reagent

Primary Device ID	00810119671875
NIH Device Record Key	86ea275c-8017-4a1c-83b8-9f008273d601
Commercial Distribution Status	In Commercial Distribution
Brand Name	H.PYLORI
Version Model Number	AM880-5M
Catalog Number	AM880-5M
Company DUNS	042697045
Company Name	BIOGENEX LABORATORIES
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	false
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	false
OTC Over-The-Counter	false

Special Storage Condition, Specify	Between 0 and 0 *Store at 2-8°C
Special Storage Condition, Specify	Between 0 and 0 *Store at 2-8°C
Special Storage Condition, Specify	Between 0 and 0 *Store at 2-8°C
Special Storage Condition, Specify	Between 0 and 0 *Store at 2-8°C
Special Storage Condition, Specify	Between 0 and 0 *Store at 2-8°C
Special Storage Condition, Specify	Between 0 and 0 *Store at 2-8°C
Special Storage Condition, Specify	Between 0 and 0 *Store at 2-8°C
Special Storage Condition, Specify	Between 0 and 0 *Store at 2-8°C
Special Storage Condition, Specify	Between 0 and 0 *Store at 2-8°C
Special Storage Condition, Specify	Between 0 and 0 *Store at 2-8°C
Special Storage Condition, Specify	Between 0 and 0 *Store at 2-8°C
Special Storage Condition, Specify	Between 0 and 0 *Store at 2-8°C
Special Storage Condition, Specify	Between 0 and 0 *Store at 2-8°C
Special Storage Condition, Specify	Between 0 and 0 *Store at 2-8°C
Special Storage Condition, Specify	Between 0 and 0 *Store at 2-8°C

Device Issuing Agency	Device ID
GS1	00810119671875 [Primary]

MVU	Reagents, Specific, Analyte

Steralize Prior To Use	false
Device Is Sterile	false

Mark Image Registration \| Serial	Company Trademark Application Date
H.PYLORI 98520081 not registered Live/Pending	Xian, Haiquan 2024-04-25