AccessGUDID - DEVICE: Progesterone ELISA (00840239015617)

GUDID

Device Identifier (DI) Information

Brand Name: Progesterone ELISA
Version or Model: EIA-1561
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EIA-1561
Company Name: DRG International Inc

Primary DI Number: 00840239015617
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 075150847 *Terms of Use

Device Description: The DRG Progesterone ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of Progesterone in serum or plasma (EDTA, lithium heparin or citrate plasma)

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?
58408	Insulin-like growth factor I (IGF1) 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 insulin-like growth factor I (IGF1), also referred to as somatomedin C, in a clinical specimen, using an enzyme immunoassay (EIA) method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JLS	Radioimmunoassay, Progesterone

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: 76736381-2286-4a1f-99e2-c76c9c169a4e
Public Version Date: August 31, 2023
Public Version Number: 1
DI Record Publish Date: August 23, 2023