FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIAGNOSTIC HYBRIDS D3 DFA VARICELLA-ZOSTER VIRUS IDENTIFICATION KIT, 01-020000
K Number: K070206
·
Decision Aug 30, 2007
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
9
Applicant Total
37
Review Days
220
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Basic Information
- Device Name
- DIAGNOSTIC HYBRIDS D3 DFA VARICELLA-ZOSTER VIRUS IDENTIFICATION KIT, 01-020000
- K Number
- K070206
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3900
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Diagnostic Hybrids, Inc.
- Date Received
- January 22, 2007
- Decision Date
- August 30, 2007
- Product Code
- GQW
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GQW | Antigen, Cf, (Including Cf Control), Varicella-Zoster | FDA class 2 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GQW), ordered by most recent decision date.
LIGHT DIAGNOSTICS SIMULFLUOR HSV/VZV IMMUNOFLOURESCENCE ASSAY, MODEL 3295
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FDA Class 2
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VZVSCAN(TM) LATEX AGGUTINATION TEST
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FDA Class 2
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VARICELLA-ZOSTER VIRUS ANTIBODY TEST KIT-LATEX AGG
FDA 510(k)
FDA Class 2
·Microbiology
VARICELLA ZOSTER VIRUS
FDA 510(k)
FDA Class 2
·Microbiology
Other Clearances by Diagnostic Hybrids, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| DEN140004 | QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY | May 13, 2014 | Unknown |
| K092229 | THYRETAIN TM TSI REPORTER BIOASSAY | May 18, 2010 | Substantially Equivalent |
| K093415 | D3 FASTPOINT L-DFA PARAINFLUENZA VIRUS/ADENOVIRUS IDENTIFICATION KIT | Dec 23, 2009 | Substantially Equivalent |
| K093233 | D3 FASTPOINT L-DFA RSV/MVP IDENTIFICATION KIT | Dec 4, 2009 | Substantially Equivalent |
| K092882 | D3 FASTPOINT L-DFA INFLUENZA A/INFLUENZA B VIRUS IDENTIFICATION KIT | Oct 21, 2009 | Substantially Equivalent |
| K091171 | D3 ULTRA DUET DFA RESPIRATORY VIRUS IDENTIFICATION KIT | Sep 11, 2009 | Substantially Equivalent |
| K092300 | MODIFICATION TO D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT | Aug 28, 2009 | Substantially Equivalent |
| K091753 | ELVIS HSV ID AND D3 TYPING TEST SYSTEM | Aug 28, 2009 | Substantially Equivalent |
| K083391 | THYROID STIMULATING IMMUNOGLOBULIN REPORTER ASSAY | May 21, 2009 | Substantially Equivalent |
| K090073 | D3 DFA METAPNEUMOVIRUS IDENTIFICATION KIT | Mar 6, 2009 | Substantially Equivalent |