Duns Number:373904101
Device Description: SpermMar IgG Positive Control: Control for use with the Indirect Test for Determination of SpermMar IgG Positive Control: Control for use with the Indirect Test for Determination of Sperm Antibodies (SpermMar IgG).More information can be found on the FertiPro website: www.fertipro.com
Catalog Number
-
Brand Name
SpermMar IgG Positive Control
Version/Model Number
SPMG_P
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"
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For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KTO
Product Code Name
Reagent, Immunoassay, Igg
Public Device Record Key
1c5366b8-c8b8-41f6-b9dc-d73b800b27c2
Public Version Date
December 11, 2019
Public Version Number
2
DI Record Publish Date
August 22, 2018
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 | 27 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 34 |