ELVIS HSV ID AND D3 TYPING TEST SYSTEM— 510(k) K091753
Substantially EquivalentDiagnostic Hybrids, Inc.
FDA 510(k) clearance K091753 for ELVIS HSV ID AND D3 TYPING TEST SYSTEM, Substantially Equivalent on 2009-08-28. Applicant: Diagnostic Hybrids, Inc.. Device class: 2.
Clearance details
- Applicant
- Diagnostic Hybrids, Inc.
- Product code
- Code GQL
- Device class
- Class 2
- Regulation
- 21 CFR 866.3305
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Athens, OH, US
Recent devices under product code GQL
view all- K081527 — LIGHT DIAGNOSTICS HSV 1/2 TYPING DFA KIT
- K984120 — THE APTUS(AUTOMATED) APPLICATION OF THE HSV-2 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR TH
- K984135 — THE APTUS (AUTOMATED) APPLICATION OF THE HSV-1 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR
- K905608 — INDIRECT FLUORESCENT ASSAY FOR HERPES SIMPLEX 1
- K904095 — HERPES SIMPLEX VIRUS TISSUE CULTURE CONF. TYPING
More clearances from Diagnostic Hybrids, Inc.
view all- DEN140004 — QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY
- K092229 — THYRETAIN TM TSI REPORTER BIOASSAY
- K093415 — D3 FASTPOINT L-DFA PARAINFLUENZA VIRUS/ADENOVIRUS IDENTIFICATION KIT
- K093233 — D3 FASTPOINT L-DFA RSV/MVP IDENTIFICATION KIT
- K092882 — D3 FASTPOINT L-DFA INFLUENZA A/INFLUENZA B VIRUS IDENTIFICATION KIT
Data sourced from openFDA. This site is unofficial and independent of the FDA.