Atellica IM aHBe2

Basic Information

• Brand Name: Atellica IM aHBe2
• Primary DI: 00842768022678
• Version / Model: 10733021
• Catalog Number: 10733021
• Company Name: Siemens Healthcare Diagnostics Inc.
• Labeler DUNS: 064608573
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-05-05
• Public Version: 2
• Public Version Date: 2022-11-21
• Public Version Status: Update
• Public Device Record Key: 223174b3-2a46-4fb9-9c47-f744d40dda49

Device Description

Anti-HBe2 (aHBe2) – Atellica IM – RGT 50T

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LOM	Test, hepatitis b (b core, be antigen, be antibody, b core igm)	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
48348	Hepatitis B virus e-antigen total antibody IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total antibodies to the Hepatitis B virus e-antigen in a clinical specimen, using a chemiluminescent immunoassay method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00842768022678	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P200017	001

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store upright, protect from light, do not freeze, resuspend
• Type: Handling Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius