Primary Device ID | B35000400R0 |
NIH Device Record Key | ddb57926-b558-427b-a81e-7eed0262fc7c |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | AIX1000 Analyzer |
Version Model Number | 00400R |
Catalog Number | 00400R |
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 | false |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B35000400R0 [Primary] |
GMQ | Antigens, Nontreponemal, All |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-11-08 |
Device Publish Date | 2023-10-31 |
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B350GSD051600MW0 - Microtiterplates (5) | 2024-10-30 Microtiterplates (5) |
B35000300CLR0 - ThunderBolt EIA (CLIA) | 2023-11-08 ThunderBolt EIA-CLIA (refurbished) |
B35000300R0 - ThunderBolt EIA | 2023-11-08 ThunderBolt EIA (refurbished) |
B35000400R0 - AIX1000 Analyzer | 2023-11-08AIX1000 Rapid Plasma Reagin (RPR) Analyzer (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 |