Product code GMD— Microbiology
(CALAS(TM)) W/ADD'L REAGENT CALAS(TM) PRONASE
- Classification name
- Antisera, Latex Agglutination, Cryptococcus Neoformans
- Device class
- Class 2
- Regulation
- 21 CFR 866.3165
- Advisory panel
- Microbiology
- Total cleared
- 10
- First cleared
- Most recent
Market context for product code GMD
FDA has cleared devices under product code GMD between 1978 and 2012, filed by 6 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2012
- 2011
- 1994
- 1993
- 1989
- 1981
- 1980
- 1979
- 1978
Top applicants under product code GMD
Recent clearances under product code GMD
- K112422 — CRAG LATERAL FLOW ASSAY (LFA)
- K102286 — CRAG LATERAL FLOW ASSAY (CRAG LFA)
- K930418 — CRYPTO-LEX SYSTEM
- K933997 — PROSPECT ENTAMOEBA HISTOLYTICA MICROPLATE ASSAY
- K894845 — (CALAS(TM)) W/ADD'L REAGENT CALAS(TM) PRONASE
- K812188 — CRYPTOCOCCAL ANTIGEN LATEX AGGLUTI
- K810510 — YA-CRYPTO ANTIBODY TUBE AGGLUTINATION
- K792693 — CRYPTOCOCCUS NEOFORMANS ANTISERUM, LATEX
- K791382 — CRYPTOCOCCAL ANTIGEN LATEX AGGLUTINATION
- K780526 — CRYPTOCOCCAL ANTIGEN LATEX AGG. SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.