AccessGUDID - DEVICE: Erythropoietin ELISA (B24221EPOHUE010)

GUDID

Device Identifier (DI) Information

Brand Name: Erythropoietin ELISA
Version or Model: 21-EPOHU-E01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 21-EPOHU-E01
Company Name: AMERICAN LABORATORY PRODUCTS COMPANY, LTD.

Primary DI Number: B24221EPOHUE010
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 784143778 *Terms of Use

Device Description: The EPO ELISA is intended for use in the quantitative determination of Erythropoietin (EPO) in human serum. This assay is intended for in vitro diagnostic use, as an aid in the diagnosis of anemias and polycythemias.

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:	Yes
Prescription Use (Rx):	Yes
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?
54149	Erythropoietin (EPO) IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the quantitative measurement of erythropoietin (EPO) in a clinical specimen, using a chemiluminescent immunoassay method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GGT	Assay, Erythropoietin

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K992799	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: 99201864-0ee6-43bc-8793-db555beaeefe
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: August 03, 2017