AccuDiag™ Mycoplasma pneumoniae IgG ELISA 8042-2
GUDID 00850082766024
AccuDiag™ Mycoplasma pneumoniae IgG ELISA The ELISA Mycoplasma pneumoniae IgG Test System provides a means for the qualitative detection of IgG antibodies to Mycoplasma pneumoniae in human sera. The test may aid in the determination of the patient’s serological status or may aid in the diagnosis of disease associated with Mycoplasma pneumoniae.
Diagnostic Automation, Inc.
Mycoplasma pneumoniae immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)| Primary Device ID | 00850082766024 |
| NIH Device Record Key | 95948a9d-1beb-4197-b5c4-376b36ca25c4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AccuDiag™ Mycoplasma pneumoniae IgG ELISA |
| Version Model Number | DACD8042-2 |
| Catalog Number | 8042-2 |
| Company DUNS | 878252071 |
| Company Name | Diagnostic Automation, Inc. |
| 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 | 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 |
Customer Support Contacts
| Phone | 8185913030 |
| onestep@rapidtest.com | |
| Phone | 8185913030 |
| onestep@rapidtest.com | |
| Phone | 8185913030 |
| onestep@rapidtest.com | |
| Phone | 8185913030 |
| onestep@rapidtest.com | |
| Phone | 8185913030 |
| onestep@rapidtest.com | |
| Phone | 8185913030 |
| onestep@rapidtest.com | |
| Phone | 8185913030 |
| onestep@rapidtest.com | |
| Phone | 8185913030 |
| onestep@rapidtest.com | |
| Phone | 8185913030 |
| onestep@rapidtest.com | |
| Phone | 8185913030 |
| onestep@rapidtest.com | |
| Phone | 8185913030 |
| onestep@rapidtest.com |
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Operating and Storage Conditions
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850082766024 [Primary] |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-03-10 |
| Device Publish Date | 2026-03-02 |
Devices Manufactured by Diagnostic Automation, Inc.
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| 00850082766024 - AccuDiag™ Mycoplasma pneumoniae IgG ELISA | 2026-03-10AccuDiag™ Mycoplasma pneumoniae IgG ELISA The ELISA Mycoplasma pneumoniae IgG Test System provides a means for the qualitative detection of IgG antibodies to Mycoplasma pneumoniae in human sera. The test may aid in the determination of the patient’s serological status or may aid in the diagnosis of disease associated with Mycoplasma pneumoniae. |
| 00850082766024 - AccuDiag™ Mycoplasma pneumoniae IgG ELISA | 2026-03-10 AccuDiag™ Mycoplasma pneumoniae IgG ELISA The ELISA Mycoplasma pneumoniae IgG Test System provides a means for the qualitative |
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Trademark Results [AccuDiag]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ACCUDIAG 85042566 4091726 Live/Registered |
Diagnostic Automation, Inc. 2010-05-19 |
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