Primary Device ID | 03661540952326 |
NIH Device Record Key | 8114bb40-125a-46dd-9424-adbe66bf4dc4 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | MGB Alert® BKV ASR v3.0 Probe Mix |
Version Model Number | M800733 |
Company DUNS | 117458512 |
Company Name | Elitechgroup Mdx LLC |
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 | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
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 0 Degrees Celsius and -10 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 03661540952326 [Primary] |
MVU | Reagents, Specific, Analyte |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-10-10 |
Device Publish Date | 2022-09-30 |
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Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
MGB ALERT 78702861 3184945 Live/Registered |
ELITECHGROUP B.V. 2005-08-29 |