AccuDiag™ C-Peptide ELISA Kit 1293-15
GUDID 00850054026255
AccuDiag™ C-Peptide ELISA Kit A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of C-peptide in a clinical specimen, using an enzyme immunoassay (EIA) method. It is typically used in the evaluation of insulin levels as an aid in the diagnosis of hypoglycaemia and insulinoma.
Diagnostic Automation, Inc.
C-peptide IVD, kit, enzyme immunoassay (EIA)| Primary Device ID | 00850054026255 |
| NIH Device Record Key | 7252fbb3-2c47-4541-b5a4-ad077105b6b3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AccuDiag™ C-Peptide ELISA Kit |
| Version Model Number | DACD1293-15 |
| Catalog Number | 1293-15 |
| 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 | |
| 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 | 00850054026255 [Primary] |
FDA Product Code
| JKD | Radioimmunoassay, C-Peptides Of Proinsulin |
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 | 2026-02-04AccuDiag™ C-Peptide ELISA Kit A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of C-peptide in a clinical specimen, using an enzyme immunoassay (EIA) method. It is typically used in the evaluation of insulin levels as an aid in the diagnosis of hypoglycaemia and insulinoma. |
| 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 | 2026-02-04 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 |
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