AccessGUDID - DEVICE: Atellica IM AMH (00842768022401)

GUDID

Device Identifier (DI) Information

Brand Name: Atellica IM AMH
Version or Model: 10998433
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10998433
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00842768022401
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: AMH – Atellica IM – RGT – 100T

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
64335	Anti-Mullerian hormone (AMH) IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the quantitative measurement of anti-Mullerian hormone (AMH) in a clinical specimen, using a chemiluminescent immunoassay method. AMH is typically used as a marker for ovarian reserve.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PQO	Anti-Müllerian hormone test system

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K221801	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 512b0fcf-440e-424e-b183-df6a4ade873e
Public Version Date: July 13, 2023
Public Version Number: 1
DI Record Publish Date: July 05, 2023