AccessGUDID - DEVICE: ACTH [Adrenocorticotropic Hormone] ELISA (00083059070231)

GUDID

Device Identifier (DI) Information

Brand Name: ACTH [Adrenocorticotropic Hormone] ELISA
Version or Model: 7023
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BIOMERICA, INC.

Primary DI Number: 00083059070231
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 067647321 *Terms of Use

Device Description: The Biomerica ACTH ELISA is intended for the quantitative determination of ACTH (Adrenocorticotropic Hormone) in human plasma. This assay is intended for in vitro diagnostic use.

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?
54056	Adrenocorticotropic hormone (ACTH) IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of the adrenocorticotropic hormone (ACTH) in a clinical specimen, using an enzyme immunoassay (EIA) method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CKG	Radioimmunoassay, Acth

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K982608	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: c9289fd8-3b06-45cc-a3f9-3038e810ad98
Public Version Date: July 09, 2020
Public Version Number: 1
DI Record Publish Date: July 01, 2020