Primary Device ID | 04049016027669 |
NIH Device Record Key | ca4cbfd9-818d-451e-a545-72f04dae695e |
Commercial Distribution Discontinuation | 2019-03-01 |
Commercial Distribution Status | Not in Commercial Distribution |
Brand Name | Anti-Mycoplasma pneumoniae ELISA (IgM) |
Version Model Number | EI 2202-9601 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 | 04049016027669 [Primary] |
LJZ | Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2019-03-01 |
Device Publish Date | 2016-09-24 |
04049016151876 - Sample buffer 2, Crithidia luciliae sensitive (IFA) | 2025-03-14 |
04049016151890 - Sample buffer 2, Crithidia luciliae sensitive (IFA) | 2025-03-14 |
04049016151920 - PBS-Tween (IFA) | 2025-03-12 |
04049016151883 - Sample buffer (IFA) | 2025-03-06 |
04049016151906 - Sample buffer (IFA) | 2025-03-06 |
04049016151913 - Sample buffer (IFA) | 2025-03-06 |
04049016151937 - PBS (IFA) | 2025-03-06 |
04049016151944 - PBS (IFA) | 2025-03-06 |