ARCHITECT 02P5410
GUDID 00380740003982
ARCHITECT HE4 Controls
Abbott GmbH & Co. KG
Human epididymis protein 4 (HE4) IVD, control| Primary Device ID | 00380740003982 |
| NIH Device Record Key | ffa9c215-c09b-474e-9b4a-be2270dae598 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ARCHITECT |
| Version Model Number | 2P54-10 |
| Catalog Number | 02P5410 |
| Company DUNS | 315786293 |
| Company Name | Abbott GmbH & Co. KG |
| 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 | false |
| 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 | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx |
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 |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00380740003982 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K093957
FDA Product Code
| OIU | Test, epithelial ovarian tumor associated antigen (he4) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-06-06 |
On-Brand Devices [ARCHITECT]
| 00380740156527 | ARCHITECT Homocysteine Reagent Kit |
| 00380740150907 | Alkaline Phosphatase |
| 00380740150891 | Alkaline Phosphatase |
| 00380740145408 | ARCHITECT CA19-9XR Controls |
| 00380740145392 | ARCHITECT CA19-9XR Calibrators |
| 00380740145385 | ARCHITECT CA 125 II Reagent Kit |
| 00380740145378 | ARCHITECT CA 125 II Reagent Kit |
| 00380740145361 | ARCHITECT CA 125 II Reagent Kit |
| 00380740145354 | ARCHITECT CA 125 II Controls |
| 00380740145347 | ARCHITECT CA 125 II Calibrators |
| 00380740145330 | ARCHITECT CA 15-3 Reagent Kit |
| 00380740145323 | ARCHITECT CA 15-3 Reagent Kit |
| 00380740145316 | ARCHITECT CA 15-3 Reagent Kit |
| 00380740145309 | ARCHITECT CA 15-3 Controls |
| 00380740145293 | ARCHITECT CA 15-3 Calibrators |
| 00380740145286 | ARCHITECT BNP Reagent Kit |
| 00380740145279 | ARCHITECT BNP Reagent Kit |
| 00380740145262 | ARCHITECT BNP Controls |
| 00380740145255 | ARCHITECT BNP Calibrators |
| 00380740139049 | ARCHITECT B.R.A.H.M.S PCT Reagent Kit |
| 00380740139032 | ARCHITECT B.R.A.H.M.S PCT Reagent Kit |
| 00380740138912 | ARCHITECT B.R.A.H.M.S PCT Controls |
| 00380740138905 | ARCHITECT B.R.A.H.M.S PCT Calibrators |
| 00380740137304 | ARCHITECT CA19-9XR Reagent Kit |
| 00380740129040 | Total Bilirubin |
| 00380740129033 | Total Bilirubin |
| 00380740119416 | Microalbumin |
| 00380740119409 | Microalbumin Controls |
| 00380740119393 | Microalbumin Calibrators |
| 00380740117122 | ARCHITECT Syphilis TP Reagent Kit |
| 00380740117115 | ARCHITECT Syphilis TP Reagent Kit |
| 00380740112776 | ARCHITECT Intact PTH Controls |
| 00380740112769 | ARCHITECT Intact PTH Calibrators |
| 00380740105327 | ARCHITECT iVancomycin Reagent Kit |
| 00380740103545 | ARCHITECT Syphilis TP Controls |
| 00380740103538 | ARCHITECT Syphilis TP Calibrator |
| 00380740099473 | ARCHITECT 2nd Generation Testosterone Reagent Kit |
| 00380740096618 | ARCHITECT Galectin-3 Reagent Kit |
| 00380740096144 | ARCHITECT Galectin-3 Controls |
| 00380740096137 | ARCHITECT Galectin-3 Calibrators |
| 00380740082147 | ARCHITECT 25-OH Vitamin D Reagent Kit |
| 00380740082130 | ARCHITECT 25-OH Vitamin D Reagent Kit |
| 00380740082123 | ARCHITECT 25-OH Vitamin D Controls |
| 00380740082116 | ARCHITECT 25-OH Vitamin D Calibrators |
| 00380740081935 | ARCHITECT iCarbamazepine Calibrator A Multi-Pack |
| 00380740081072 | ARCHITECT iCarbamazepine Reagent Kit |
| 00380740048471 | ARCHITECT Intact PTH Reagent Kit |
| 00380740048433 | ARCHITECT HE4 Reagent Kit |
| 00380740017453 | ARCHITECT DHEA-S Reagent Kit |
| 00380740017439 | ARCHITECT DHEA-S Controls |
Trademark Results [ARCHITECT]
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.