Primary Device ID | B350GSD011002RP0 |
NIH Device Record Key | 7f03c02e-0860-463c-86f6-da347ca175aa |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | IgM Reagent Pack |
Version Model Number | GSD01-1002-RP |
Catalog Number | GSD01-1002-RP |
Company DUNS | 790524891 |
Company Name | Gold Standard Diagnostics Corporation |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
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 | false |
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 |
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 |
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 |
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 |
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 | B350GSD011002RP0 [Primary] |
PPM | General Purpose Reagent |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-11-07 |
Device Publish Date | 2022-10-28 |
B35000300CLR0 - ThunderBolt EIA (CLIA) | 2023-11-08 ThunderBolt EIA-CLIA (refurbished) |
B35000300R0 - ThunderBolt EIA | 2023-11-08 ThunderBolt EIA (refurbished) |
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 |