Atellica IM aCCP 10732998

GUDID 00630414245669

anti-CCP IgG (aCCP) Atellica IM - RGT 100T

Siemens Healthcare Diagnostics Inc.

Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, chemiluminescent immunoassay Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, chemiluminescent immunoassay Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, chemiluminescent immunoassay Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, chemiluminescent immunoassay Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, chemiluminescent immunoassay Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, chemiluminescent immunoassay Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, chemiluminescent immunoassay Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, chemiluminescent immunoassay Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, chemiluminescent immunoassay Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, chemiluminescent immunoassay Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, chemiluminescent immunoassay Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, chemiluminescent immunoassay Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, chemiluminescent immunoassay Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, chemiluminescent immunoassay Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, chemiluminescent immunoassay Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, chemiluminescent immunoassay Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, chemiluminescent immunoassay Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, chemiluminescent immunoassay Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, chemiluminescent immunoassay Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, chemiluminescent immunoassay Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, chemiluminescent immunoassay Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, chemiluminescent immunoassay Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, chemiluminescent immunoassay Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, chemiluminescent immunoassay Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, chemiluminescent immunoassay Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, chemiluminescent immunoassay Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, chemiluminescent immunoassay Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, chemiluminescent immunoassay Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, chemiluminescent immunoassay Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, chemiluminescent immunoassay Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, chemiluminescent immunoassay

Primary Device ID	00630414245669
NIH Device Record Key	b440ed0d-60b8-4377-8987-3d0f6cd3404c
Commercial Distribution Status	In Commercial Distribution
Brand Name	Atellica IM aCCP
Version Model Number	10732998
Catalog Number	10732998
Company DUNS	064608573
Company Name	Siemens Healthcare Diagnostics Inc.
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	true
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	XX@XX.XX
Phone	+1(877)229-3711
Email	XX@XX.XX
Phone	+1(877)229-3711
Email	XX@XX.XX
Phone	+1(877)229-3711
Email	XX@XX.XX
Phone	+1(877)229-3711
Email	XX@XX.XX
Phone	+1(877)229-3711
Email	XX@XX.XX
Phone	+1(877)229-3711
Email	XX@XX.XX
Phone	+1(877)229-3711
Email	XX@XX.XX
Phone	+1(877)229-3711
Email	XX@XX.XX
Phone	+1(877)229-3711
Email	XX@XX.XX
Phone	+1(877)229-3711
Email	XX@XX.XX
Phone	+1(877)229-3711
Email	XX@XX.XX
Phone	+1(877)229-3711
Email	XX@XX.XX
Phone	+1(877)229-3711
Email	XX@XX.XX
Phone	+1(877)229-3711
Email	XX@XX.XX
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

Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00630414245669 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K153551

FDA Product Code

NHX	ANTIBODIES, ANTI-CYCLIC CITRULLINATED PEPTIDE (CCP)

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	2018-11-19
Device Publish Date	2018-10-19

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