Helicobacter pylori [EPR10353]

GUDID 00847627032515

BIOCARE MEDICAL LLC

Helicobacter pylori antigen IVD, antibody Helicobacter pylori antigen IVD, antibody Helicobacter pylori antigen IVD, antibody Helicobacter pylori antigen IVD, antibody Helicobacter pylori antigen IVD, antibody Helicobacter pylori antigen IVD, antibody Helicobacter pylori antigen IVD, antibody Helicobacter pylori antigen IVD, antibody Helicobacter pylori antigen IVD, antibody Helicobacter pylori antigen IVD, antibody Helicobacter pylori antigen IVD, antibody Helicobacter pylori antigen IVD, antibody Helicobacter pylori antigen IVD, antibody Helicobacter pylori antigen IVD, antibody Helicobacter pylori antigen IVD, antibody Helicobacter pylori antigen IVD, antibody Helicobacter pylori antigen IVD, antibody
Primary Device ID00847627032515
NIH Device Record Keydb1980b6-cb6e-458c-b688-f99b289033cf
Commercial Distribution StatusIn Commercial Distribution
Brand NameHelicobacter pylori [EPR10353]
Version Model NumberALA3291G7
Company DUNS806617825
Company NameBIOCARE MEDICAL LLC
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100847627032515 [Primary]

FDA Product Code

MVUReagents, Specific, Analyte

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-10-30
Device Publish Date2023-10-20

On-Brand Devices [Helicobacter pylori [EPR10353]]

00847627032546OPAA3291T60
00847627032515ALA3291G7
00847627032508AVA3291G
00847627032492APA3291AA
00847627032485ACA3291C
00847627032478ACA3291A
00847627035851APA3291H

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