AccuDiag™ 17-alpha-OH Progesterone ELISA 1292-15
GUDID 00894175000770
AccuDiag™ 17-alpha-OH Progesterone ELISA A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of 17-hydroxyprogesterone in a clinical specimen, using an enzyme immunoassay (EIA) method
Diagnostic Automation, Inc.
17-Hydroxyprogesterone IVD, kit, enzyme immunoassay (EIA)| Primary Device ID | 00894175000770 |
| NIH Device Record Key | 6bd3a48b-f2e7-457d-b1c4-ed5ce96d41fa |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AccuDiag™ 17-alpha-OH Progesterone ELISA |
| Version Model Number | DACD1292-15 |
| Catalog Number | 1292-15 |
| Company DUNS | 878252071 |
| Company Name | Diagnostic Automation, Inc. |
| 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 |
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 | |
| 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 |
| 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 |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00894175000770 [Primary] |
FDA Product Code
| JLX | Radioimmunoassay, 17-Hydroxyprogesterone |
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 | 2026-02-04 |
| Device Publish Date | 2026-01-27 |
Devices Manufactured by Diagnostic Automation, Inc.
| 00850049545723 - AccuDiag™ Insulin ELISA | 2026-02-04 AccuDiag™ Insulin ELISA A collection of reagents and other associated materials intended to be used for the quantitative measu |
| 00850049545815 - AccuDiag™ Human Growth Hormone (HGH) ELISA | 2026-02-04 AccuDiag™ Human Growth Hormone (HGH) ELISA A collection of reagents and other associated materials intended to be used for the |
| 00850054026255 - AccuDiag™ C-Peptide ELISA Kit | 2026-02-04 AccuDiag™ C-Peptide ELISA Kit A collection of reagents and other associated materials intended to be used for the qualitative |
| 00850054026682 - AccuDiag™ Estradiol ELISA | 2026-02-04 AccuDiag™ Estradiol ELISA Kit A collection of reagents and other associated materials intended to be used for the quantitative |
| 00850054026705 - AccuDiag™ FSH ELISA | 2026-02-04 AccuDiag™ FSH ELISA |
| 00850082766017 - AccuDiag™ Free Estriol ELISA | 2026-02-04 AccuDiag™ Free Estriol ELISA A collection of reagents and other associated materials intended to be used for the qualitative |
| 00894175000770 - AccuDiag™ 17-alpha-OH Progesterone ELISA | 2026-02-04AccuDiag™ 17-alpha-OH Progesterone ELISA A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of 17-hydroxyprogesterone in a clinical specimen, using an enzyme immunoassay (EIA) method |
| 00894175000770 - AccuDiag™ 17-alpha-OH Progesterone ELISA | 2026-02-04 AccuDiag™ 17-alpha-OH Progesterone ELISA A collection of reagents and other associated materials intended to be used for the q |
| 00894175000824 - AccuDiag™ ANST (Androstenedione) ELISA | 2026-02-04 AccuDiag™ ANST (Androstenedione) ELISA |
Trademark Results [AccuDiag]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ACCUDIAG 85042566 4091726 Live/Registered |
Diagnostic Automation, Inc. 2010-05-19 |
© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.