FDA device listing
AnaeroGro Brucella Agar w Hemin and Vit K,AnaeroGroTM Brucella w/H&K,AnaeroGroTM Chopped Meat Broth,AnaeroGroTM Chopped…
FDA device listing 1540315510 · HARDY DIAGNOSTICS
Key facts
| Proprietary names | AnaeroGro Brucella Agar w Hemin and Vit K,AnaeroGroTM Brucella w/H&K,AnaeroGroTM Chopped Meat Broth,AnaeroGroTM Chopped Meat Carbo Broth,AnaeroGroTM Chopped Meat Gluc. Broth,BCYE Agar,BCYE Agar w/o Cysteine,BHI Agar w/5% SB,BHI Agar w/Blood,BHI Broth w/5% Fildes,BHI w/H&K,Blood Agar, 10%,Blood Agar, 5%,Blood Agar 5%, EH,Blood Agar 5% (RSR),Blood Agar, 5%, Slant,Blood Agar, 8%,Blood Agar… |
|---|---|
| Owner/operator | HARDY DIAGNOSTICS |
| Owner/operator number | 2022807 |
| Product codes | KZI |
| Device names | KZI - Culture Media, Enriched |
| Device class | Class I |
| Classification regulations (21 CFR) | 866.2330 |
| Review panels | Microbiology |
| Registered establishments | Hardy Diagnostics, HARDY DIAGNOSTICS |
| Establishment registrations | 2022807, 3009547954 |
| FEI numbers | 2022807, 3009547954 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database