Primary Device ID | B3507206500 |
NIH Device Record Key | f8913798-be86-40f9-869b-9b6b52156426 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Gold Standard Diagnostics Is-EBV-EA-D IgM Test Kit |
Version Model Number | 720-650 |
Catalog Number | 720-650 |
Company DUNS | 790524891 |
Company Name | Gold Standard Diagnostics Corporation |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B3507206500 [Primary] |
LSE | Epstein-Barr Virus, Other |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-12-15 |
Device Publish Date | 2022-12-07 |
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B35000400R0 - AIX1000 Analyzer | 2023-11-08 AIX1000 Rapid Plasma Reagin (RPR) Analyzer (refurbished) |
B35000500CLR0 - Bolt (CLIA) | 2023-11-08 Bolt EIA-CLIA (refurbished) |
B35000500R0 - Bolt | 2023-11-08 Bolt EIA (refurbished) |
B350GSD011600DYE0 - AIX1000 Performance Check Dye Kit | 2023-09-21 AIX1000 Performance Check Dye Kit |
B350GSD0124500 - Performance Check Dye Kit | 2023-09-21 Performance Check Dye Kit |
B350GSD051600NC0 - RPR Non-Reactive Control | 2023-09-21 RPR Non-Reactive Control |