ANAEROBE SYSTEMS
Registration 2916932FEI 2916932MORGAN HILL, CA
Owner/operator: Biolog Inc
- Complaint File Establishment per 21 CFR 820.198
- Manufacture 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
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- Dec 1Our pay-by date30 days left
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- FDA fee, FY2027
- $13,785
- Our pay-by suggestion
- Dec 1
- Listed devices
- 9
- Added, last 12 months
- 9
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 9
| Code | Device | Class | Regulation | Premarket |
|---|---|---|---|---|
| JTM | AS-150 Anaerobic ChamberAnaerobic Box GloveAdded Dec 10, 2025 | Class 1 | 21 CFR 866.2120 | — |
| JSL | ANAEROBIC TISSUE TRANSPORT8mLCulture Media, Anaerobic TransportAdded Dec 10, 2025 | Class 1 | 21 CFR 866.2390 | K834357 |
| KZI | BHIY-HTCulture Media, EnrichedAdded Dec 10, 2025 | Class 1 | 21 CFR 866.2330 | — |
| JSC | BRU BROTHCulture Media, General Nutrient BrothAdded Dec 10, 2025 | Class 1 | 21 CFR 866.2350 | — |
| JSH | BRU 150 mmCulture Media, Non-Selective And DifferentialAdded Dec 10, 2025 | Class 1 | 21 CFR 866.2320 | — |
| JSG | BHICulture Media, Non-Selective And Non-DifferentialAdded Dec 10, 2025 | Class 1 | 21 CFR 866.2300 | — |
| JSI | BBE QUADSCulture Media, Selective And DifferentialAdded Dec 10, 2025 | Class 1 | 21 CFR 866.2360 | — |
| JSJ | BIFIDOCulture Media, Selective And Non-DifferentialAdded Dec 10, 2025 | Class 1 | 21 CFR 866.2360 | — |
| JTO | CATALASE REAGENTDiscs, Strips And Reagents, Microorganism DifferentiationAdded Dec 10, 2025 | Class 1 | 21 CFR 866.2660 | — |
What changed
- Dec 10, 2025Listing added: JTM — AS-150 Anaerobic Chamber
- Dec 10, 2025Listing added: JSL — ANAEROBIC TISSUE TRANSPORT8mL (K834357)
- Dec 10, 2025Listing added: KZI — BHIY-HT
- Dec 10, 2025Listing added: JSC — BRU BROTH
- Dec 10, 2025Listing added: JSH — BRU 150 mm
- Dec 10, 2025Listing added: JSG — BHI
- Dec 10, 2025Listing added: JSI — BBE QUADS
- Dec 10, 2025Listing added: JSJ — BIFIDO
- Dec 10, 2025Listing added: JTO — CATALASE REAGENT