Atellica IM tIgE DIL 10995616

GUDID 00630414599397

IgE Multi-Diluent Atellica IM - CONS (2PK) 2 x 5mL

Siemens Healthcare Diagnostics Inc.

Buffered sample diluent IVD, automated/semi-automated system Buffered sample diluent IVD, automated/semi-automated system Buffered sample diluent IVD, automated/semi-automated system Buffered sample diluent IVD, automated/semi-automated system Buffered sample diluent IVD, automated/semi-automated system Buffered sample diluent IVD, automated/semi-automated system Buffered sample diluent IVD, automated/semi-automated system Buffered sample diluent IVD, automated/semi-automated system Buffered sample diluent IVD, automated/semi-automated system Buffered sample diluent IVD, automated/semi-automated system Buffered sample diluent IVD, automated/semi-automated system Buffered sample diluent IVD, automated/semi-automated system Buffered sample diluent IVD, automated/semi-automated system Buffered sample diluent IVD, automated/semi-automated system Buffered sample diluent IVD, automated/semi-automated system Buffered sample diluent IVD, automated/semi-automated system Buffered sample diluent IVD, automated/semi-automated system Buffered sample diluent IVD, automated/semi-automated system Buffered sample diluent IVD, automated/semi-automated system Buffered sample diluent IVD, automated/semi-automated system Buffered sample diluent IVD, automated/semi-automated system Buffered sample diluent IVD, automated/semi-automated system Buffered sample diluent IVD, automated/semi-automated system Buffered sample diluent IVD, automated/semi-automated system Buffered sample diluent IVD, automated/semi-automated system Buffered sample diluent IVD, automated/semi-automated system Buffered sample diluent IVD, automated/semi-automated system Buffered sample diluent IVD, automated/semi-automated system Buffered sample diluent IVD, automated/semi-automated system Buffered sample diluent IVD, automated/semi-automated system Buffered sample diluent IVD, automated/semi-automated system Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD

Primary Device ID	00630414599397
NIH Device Record Key	b0972d6c-d8dd-4f55-9f88-55c8df9a158b
Commercial Distribution Status	In Commercial Distribution
Brand Name	Atellica IM tIgE DIL
Version Model Number	10995616
Catalog Number	10995616
Company DUNS	064608573
Company Name	Siemens Healthcare Diagnostics Inc.
Device Count	2
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
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
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright
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
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright

Device Identifiers

Device Issuing Agency	Device ID
GS1	00630414007618 [Unit of Use]
GS1	00630414599397 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K920372

FDA Product Code

DGC	IGE, ANTIGEN, ANTISERUM, CONTROL

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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