Atellica IM CKMB MCM 10995534

GUDID 00630414598611

CKMB - Atellica IM - Master Curve Material Kit 10 x 1 x 1.0mL

Siemens Healthcare Diagnostics Inc.

Creatine kinase myocardial isoenzyme (CKMB) IVD, control Creatine kinase myocardial isoenzyme (CKMB) IVD, control Creatine kinase myocardial isoenzyme (CKMB) IVD, control Creatine kinase myocardial isoenzyme (CKMB) IVD, control Creatine kinase myocardial isoenzyme (CKMB) IVD, control Creatine kinase myocardial isoenzyme (CKMB) IVD, control Creatine kinase myocardial isoenzyme (CKMB) IVD, control Creatine kinase myocardial isoenzyme (CKMB) IVD, control Creatine kinase myocardial isoenzyme (CKMB) IVD, control Creatine kinase myocardial isoenzyme (CKMB) IVD, control Creatine kinase myocardial isoenzyme (CKMB) IVD, control Creatine kinase myocardial isoenzyme (CKMB) IVD, control Creatine kinase myocardial isoenzyme (CKMB) IVD, control Creatine kinase myocardial isoenzyme (CKMB) IVD, control Creatine kinase myocardial isoenzyme (CKMB) IVD, control Creatine kinase myocardial isoenzyme (CKMB) IVD, control Creatine kinase myocardial isoenzyme (CKMB) IVD, control Creatine kinase myocardial isoenzyme (CKMB) IVD, control Creatine kinase myocardial isoenzyme (CKMB) IVD, control Creatine kinase myocardial isoenzyme (CKMB) IVD, control Creatine kinase myocardial isoenzyme (CKMB) IVD, control Creatine kinase myocardial isoenzyme (CKMB) IVD, control Creatine kinase myocardial isoenzyme (CKMB) IVD, control Creatine kinase myocardial isoenzyme (CKMB) IVD, control Creatine kinase myocardial isoenzyme (CKMB) IVD, control Creatine kinase myocardial isoenzyme (CKMB) IVD, control Creatine kinase myocardial isoenzyme (CKMB) IVD, control Creatine kinase myocardial isoenzyme (CKMB) IVD, control Creatine kinase myocardial isoenzyme (CKMB) IVD, control Creatine kinase myocardial isoenzyme (CKMB) IVD, control Creatine kinase myocardial isoenzyme (CKMB) IVD, control

Primary Device ID	00630414598611
NIH Device Record Key	1edb260e-db5a-4bba-9eac-3125931c4d8a
Commercial Distribution Status	In Commercial Distribution
Brand Name	Atellica IM CKMB MCM
Version Model Number	10995534
Catalog Number	10995534
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	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	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
Special Storage Condition, Specify	Between 0 and 0 *Store Upright, Do not freeze, Resuspend.
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Upright, Do not freeze, Resuspend.
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Upright, Do not freeze, Resuspend.
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Upright, Do not freeze, Resuspend.
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Upright, Do not freeze, Resuspend.
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Upright, Do not freeze, Resuspend.
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Upright, Do not freeze, Resuspend.
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Upright, Do not freeze, Resuspend.
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Upright, Do not freeze, Resuspend.
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Upright, Do not freeze, Resuspend.
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Upright, Do not freeze, Resuspend.
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Upright, Do not freeze, Resuspend.
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Upright, Do not freeze, Resuspend.
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Upright, Do not freeze, Resuspend.
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Upright, Do not freeze, Resuspend.
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Upright, Do not freeze, Resuspend.
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Upright, Do not freeze, Resuspend.
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Upright, Do not freeze, Resuspend.
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Upright, Do not freeze, Resuspend.
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Upright, Do not freeze, Resuspend.
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Upright, Do not freeze, Resuspend.
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Upright, Do not freeze, Resuspend.
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Upright, Do not freeze, Resuspend.
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Upright, Do not freeze, Resuspend.
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Upright, Do not freeze, Resuspend.
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Upright, Do not freeze, Resuspend.
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Upright, Do not freeze, Resuspend.
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Upright, Do not freeze, Resuspend.
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store Upright, Do not freeze, Resuspend.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00630414598611 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K962126

FDA Product Code

CDD	RADIOASSAY, VITAMIN B12

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2018-02-06

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