Duns Number:317134468
Device Description: The DRG LH ELISA Kit is an enzyme immunoassay for the quantitative in vitro diagnostic mea The DRG LH ELISA Kit is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of Luteinizing Hormone (LH) in urine.
Catalog Number
EIA-1290
Brand Name
LH-Urine ELISA
Version/Model Number
EIA-1290
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CEP
Product Code Name
RADIOIMMUNOASSAY, LUTEINIZING HORMONE
Public Device Record Key
ecb508de-7f7d-4930-bcfe-0e8d765d8604
Public Version Date
June 15, 2021
Public Version Number
1
DI Record Publish Date
June 07, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 84 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |