Atellica IM DHEAS 11206311

GUDID 00630414293844

DHEAS - Atellica IM - RGT 250T

Siemens Healthcare Diagnostics Inc.

Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, chemiluminescent immunoassay Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, chemiluminescent immunoassay Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, chemiluminescent immunoassay Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, chemiluminescent immunoassay Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, chemiluminescent immunoassay Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, chemiluminescent immunoassay Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, chemiluminescent immunoassay Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, chemiluminescent immunoassay Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, chemiluminescent immunoassay Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, chemiluminescent immunoassay Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, chemiluminescent immunoassay Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, chemiluminescent immunoassay Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, chemiluminescent immunoassay Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, chemiluminescent immunoassay Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, chemiluminescent immunoassay Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, chemiluminescent immunoassay Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, chemiluminescent immunoassay Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, chemiluminescent immunoassay Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, chemiluminescent immunoassay Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, chemiluminescent immunoassay Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, chemiluminescent immunoassay Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, chemiluminescent immunoassay Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, chemiluminescent immunoassay Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, chemiluminescent immunoassay Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, chemiluminescent immunoassay Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, chemiluminescent immunoassay Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, chemiluminescent immunoassay Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, chemiluminescent immunoassay Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, chemiluminescent immunoassay Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, chemiluminescent immunoassay Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, chemiluminescent immunoassay

Primary Device ID	00630414293844
NIH Device Record Key	cc87b908-be18-49d8-9b21-0415482d7fa9
Commercial Distribution Status	In Commercial Distribution
Brand Name	Atellica IM DHEAS
Version Model Number	11206311
Catalog Number	11206311
Company DUNS	064608573
Company Name	Siemens Healthcare Diagnostics Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	true
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, 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
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	00630414293844 [Primary]

FDA Product Code

JKC	RADIOIMMUNOASSAY, DEHYDROEPIANDROSTERONE (FREE AND SULFATE)

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	2020-12-21
Device Publish Date	2020-12-12

On-Brand Devices [Atellica IM DHEAS]

00630414293622	DHEAS - Atellica IM - RGT 50T
00630414598796	DHEAS - Atellica IM - RGT 50T
00630414293844	DHEAS - Atellica IM - RGT 250T