Primary Device ID | B350004000 |
NIH Device Record Key | 8dc581b9-91f9-484d-9731-e4bdc3ab8a8e |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | AIX1000 Analyzer |
Version Model Number | 00400 |
Company DUNS | 790524891 |
Company Name | GOLD STANDARD DIAGNOSTICS CORP. |
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 | B350004000 [Primary] |
GMQ | Antigens, Nontreponemal, All |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2016-11-29 |
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