Primary Device ID | 00607158000052 |
NIH Device Record Key | a6e480ce-31a3-4a52-9af3-0e0882e47c44 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Chembio HIV 1/2 Stat-Pak Assay |
Version Model Number | 60-9505-1 |
Company DUNS | 160348470 |
Company Name | Chembio Diagnostic Systems Inc. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | true |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
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