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- PYNFish (Fluorescence In Situ Hybridization) Kit, Nucleic Acid, Plasmodium Sp.2Product Code
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- Submissions with No Product CodeMiscellaneous
- Subpart B—Biological StainsCFR Sub-Part
- Subpart B—Clinical Chemistry Test SystemsCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Clinical Laboratory InstrumentsCFR Sub-Part
- Subpart C—Microbiology DevicesCFR Sub-Part
- Subpart D—Serological ReagentsCFR Sub-Part
- Subpart F—Immunological Test SystemsCFR Sub-Part
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ZIKV Detect 2.0 IgM Capture ELISA
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- DEN180069
- 510(k) Type
- Direct
- Applicant
- InBios International, Inc.
- Country
- United States
- FDA Decision
- Deleted
- Decision Date
- 5/23/2019
- Days to Decision
- 148 days