Primary Device ID | 04049016027201 |
NIH Device Record Key | bb5b156a-c496-4e0a-9b9f-7d3a9f4fd233 |
Commercial Distribution Discontinuation | 2017-09-11 |
Commercial Distribution Status | Not in Commercial Distribution |
Brand Name | Anti-ß2-Glycoprotein 1 ELISA (IgM) |
Version Model Number | EA 1632-9601 M |
Company DUNS | 322209263 |
Company Name | EUROIMMUN Medizinische Labordiagnostika AG |
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 | true |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 04049016027201 [Primary] |
DDN | Beta-2-Glycoprotein I, Antigen, Antiserum, Control |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2018-03-29 |
Device Publish Date | 2016-09-24 |
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