Primary Device ID | 00810040821103 |
NIH Device Record Key | 83e9822f-e3d9-4655-8f8e-c06c47e9c356 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Food Sensitivity Test |
Version Model Number | C2234 |
Company DUNS | 081257070 |
Company Name | Cue Health Inc. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
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 | false |
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 | true |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00810040821103 [Primary] |
PQD | Blood Specimen Collection Convenience Kit (Excludes Hiv) |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-05-08 |
Device Publish Date | 2024-04-30 |
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00810040821035 - Glucose + Insulin Test | 2024-05-08 Sample Collection Kit, Blood (Adx Single), Fasting Glucose & Fasting Insulin |
00810040821103 - Food Sensitivity Test | 2024-05-08Sample Collection Kit, Blood (5 DBS), Food Sensitivity Panel |
00810040821103 - Food Sensitivity Test | 2024-05-08 Sample Collection Kit, Blood (5 DBS), Food Sensitivity Panel |
00810040821059 - Women's Health Test | 2024-04-22 Sample Collection Kit, Blood (Adx Dual), Women's Health Panel |