Atellica IM HBcT2 11200739

GUDID 00630414604138

HBc Total 2 (HBcT2) Atellica IM - RGT 100T

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

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Primary Device ID	00630414604138
NIH Device Record Key	af0afc67-fdbc-491d-8853-df95cd42b80b
Commercial Distribution Status	In Commercial Distribution
Brand Name	Atellica IM HBcT2
Version Model Number	11200739
Catalog Number	11200739
Company DUNS	296822794
Company Name	SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
Device Count	1
DM Exempt	false
Pre-market Exempt	false
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

Customer Support Contacts

Phone	+1(877)229-3711
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(877)229-3711
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(877)229-3711
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(877)229-3711
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(877)229-3711
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(877)229-3711
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(877)229-3711
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(877)229-3711
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(877)229-3711
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(877)229-3711
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(877)229-3711
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(877)229-3711
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(877)229-3711
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(877)229-3711
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(877)229-3711
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(877)229-3711
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(877)229-3711
Email	CONTACT@SIEMENS-HEALTHINEERS.COM

Operating and Storage Conditions

Special Storage Condition, Specify	Between 0 and 0 *Keep away from light
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from light
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from light
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from light
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from light
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from light
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from light
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from light
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from light
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from light
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from light
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from light
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from light
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from light
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from light
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from light
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from light
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00630414604138 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Approval: P210019

FDA Product Code

LOM	Test, hepatitis b (b core, be antigen, be antibody, b core igm)

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2023-06-28
Device Publish Date	2023-06-20

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