AccessGUDID - DEVICE: Elecsys AMH (07613336166291)

GUDID

Device Identifier (DI) Information

Brand Name: Elecsys AMH
Version or Model: 08819378190
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 08819378190
Company Name: Roche Diagnostics GmbH

Primary DI Number: 07613336166291
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315028860 *Terms of Use

Device Description: No description.

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):	Yes
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 [?]
K203757	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2df1b906-f15a-49cb-b6fe-84b32b89b53b
Public Version Date: July 28, 2022
Public Version Number: 1
DI Record Publish Date: July 20, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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