H.PYLORI AM880-10M

GUDID 00810119676252

Multiple gastrointestinal disease marker IVD, reagent

Primary Device ID	00810119676252
NIH Device Record Key	ebec1aac-b391-4f10-b8c7-02465f0a7464
Commercial Distribution Status	In Commercial Distribution
Brand Name	H.PYLORI
Version Model Number	AM880-10M
Catalog Number	AM880-10M
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
Special Storage Condition, Specify	Between 0 and 0 *Store at 2-8°C

Device Issuing Agency	Device ID
GS1	00810119676252 [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