ROCHE DIABETES CARE, INC.
Registration 3011393376FEI 3011393376Indianapolis, IN
Owner/operator: Roche Diagnostics Operations Inc.
- Complaint File Establishment per 21 CFR 820.198
- Develop Specifications But Do Not Manufacture At This Facility
- Manufacture Device in the United States for Export Only
- Manufacture Medical Device
- Repack or Relabel Medical Device
Renewal due by December 31, 2026
Registered through 2026. Renew between October 1 and December 31, 2026, to stay registered for 2027.
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The 2026 window
- Oct 1Window opens91 days left
- Nov 3Where you stand58 days left
- Dec 1Our pay-by date30 days left
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- Dec 31Window closes0 days left
- FDA fee, FY2027
- $13,785
- Our pay-by suggestion
- Dec 1
- Listed devices
- 23
- Added, last 12 months
- 0
FDA sets who pays the fee and who may qualify for a waiver; its fee page says so. The fee is paid only on FDA’s own fee site. Never through us. FDA’s fee page
The steps, in order
Pay FDA's annual feeYou
Order and pay the FY2027 establishment fee on FDA's Device Facility User Fee site. FDA emails you a PIN when you order.
FDA: registration and listing payment processWait for the payment confirmation numberYou
FDA emails a Payment Confirmation Number (PCN) once the payment processes, which FDA says typically takes several days. That is why we suggest paying by December 1.
FDA: registration and listing payment processRenew the registration in FDA's systemYou
Sign in to FDA's Unified Registration and Listing System (FURLS), complete the annual registration and apply your PIN and PCN. FDA does not count the registration as complete until both are applied.
FDA: device registration and listingReview every listingYou
In the same window, review each listing on file and report any changes, deletions and new listings. Your Listing Review Sheet puts every listing on one page.
FDA: device registration and listing
Every listed device 23
| Code | Device | Class | Regulation | Premarket |
|---|---|---|---|---|
| OZP | Accu-Chek Guide Link Blood Glucose Monitoring SystemAutomated Insulin Dosing Device System, Single Hormonal Control | Class 3 | — | P160017 |
| NDC | ACCU-CHEK AVIVA ASPAC STRIP 50CTCalculator, Drug Dose | Class 2 | 21 CFR 868.1890 | K131029 |
| LFR | A/C Inform II Base Unit KitGlucose Dehydrogenase, Glucose | Class 2 | 21 CFR 862.1345 | K121679 |
| LFR | Accu-Chek Aviva test stripsGlucose Dehydrogenase, Glucose | Class 2 | 21 CFR 862.1345 | — |
| LFR | ACCU-CHEK AVIVA PLUS 25CT STRIP 36/CSGlucose Dehydrogenase, Glucose | Class 2 | 21 CFR 862.1345 | K133862 |
| LFR | ACCU-CHEK AVIVA ASPAC STRIP 50CTGlucose Dehydrogenase, Glucose | Class 2 | 21 CFR 862.1345 | K131029 |
| LFR | ACCU-CHEK NANO METER ONLYGlucose Dehydrogenase, Glucose | Class 2 | 21 CFR 862.1345 | K113137 |
| LFR | ACCU CHEK GUIDE HCP SAMPLE LAUNCH BOXGlucose Dehydrogenase, Glucose | Class 2 | 21 CFR 862.1345 | K160944 |
| QRL | ACCU-CHEK FASTCLIX KIT CANADAMultiple Use Blood Lancet For Single Patient Use Only | Class 2 | 21 CFR 878.4850 | — |
| LZG | ACCU-CHEK AVIVA ASPAC STRIP 50CTPump, Infusion, Insulin | Class 2 | 21 CFR 880.5725 | K131029 |
| QRK | ACCU-CHEK SOFTCLIX KIT CANADASingle Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | Class 2 | 21 CFR 878.4850 | — |
| NBW | ACCU CHEK GUIDE HCP SAMPLE LAUNCH BOXSystem, Test, Blood Glucose, Over The Counter | Class 2 | 21 CFR 862.1345 | K160944 |
and 11 more on your full dossier
What changed
Nothing added in the last twelve months, and no change seen on the record yet.