Atellica IM FSH 10995581

GUDID 00630414599052

Follicle Stimulating Hormone (FSH) Atellica IM - RGT 950T

Siemens Healthcare Diagnostics Inc.

Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay

Primary Device ID	00630414599052
NIH Device Record Key	8780fce4-162b-42bf-8bed-18e28bcea927
Commercial Distribution Status	In Commercial Distribution
Brand Name	Atellica IM FSH
Version Model Number	10995581
Catalog Number	10995581
Company DUNS	064608573
Company Name	Siemens Healthcare Diagnostics Inc.
Device Count	5
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	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 *Store upright, Protect from light
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright, Protect from light
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright, Protect from light
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright, Protect from light
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright, Protect from light
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright, Protect from light
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright, Protect from light
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright, Protect from light
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright, Protect from light
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright, Protect from light
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright, Protect from light
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright, Protect from light
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright, Protect from light
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright, Protect from light
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, Protect from light
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright, Protect from light
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright, Protect from light
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright, Protect from light
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright, Protect from light
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright, Protect from light
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright, Protect from light
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright, Protect from light
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright, Protect from light
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright, Protect from light
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright, Protect from light
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright, Protect from light
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright, Protect from light
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright, Protect from light
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright, Protect from light
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store upright, Protect from light

Device Identifiers

Device Issuing Agency	Device ID
GS1	00630414007557 [Unit of Use]
GS1	00630414599052 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K904649

FDA Product Code

CGJ	RADIOIMMUNOASSAY, FOLLICLE-STIMULATING HORMONE

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

On-Brand Devices [Atellica IM FSH]

00630414294179	Follicle Stimulating Hormone (FSH) - Atellica IM - RGT 950T
00630414599052	Follicle Stimulating Hormone (FSH) Atellica IM - RGT 950T
00630414599045	Follicle Stimulating Hormone (FSH) Atellica IM - RGT 190T