Atellica IM BNP MCM 10995474

GUDID 00630414598017

BNP Atellica IM - Master Curve Material Kit 5 x 1 x 1.0mL

Siemens Healthcare Diagnostics Inc.

B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control

Primary Device ID	00630414598017
NIH Device Record Key	4543f368-ca8b-45fd-a222-530d8d170a57
Commercial Distribution Status	In Commercial Distribution
Brand Name	Atellica IM BNP MCM
Version Model Number	10995474
Catalog Number	10995474
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
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.
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	00630414598017 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K031038

FDA Product Code

JJX	Single (specified) analyte controls (assayed and unassayed)

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	2020-10-02
Device Publish Date	2020-09-24

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