AccessGUDID - DEVICE: Prolactin ELISA (B24220PROHUE010)

GUDID

Device Identifier (DI) Information

Brand Name: Prolactin ELISA
Version or Model: 20-PROHU-E01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 20-PROHU-E01
Company Name: AMERICAN LABORATORY PRODUCTS COMPANY, LTD.

Primary DI Number: B24220PROHUE010
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 784143778 *Terms of Use

Device Description: The Prolactin ELISA is an enzyme immunoassay for the quantitative determination of Prolactin in human serum. For in vitro diagnostic use in the United States of America. For research use only in other territories.

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:	Yes
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?
54337	Prolactin IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of prolactin in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CFT	Radioimmunoassay, Prolactin (Lactogen)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: b367c64b-376a-41c1-bfca-3af422341b52
Public Version Date: March 02, 2023
Public Version Number: 1
DI Record Publish Date: February 22, 2023