Heart Disease Risk Test: Lipoprotein a + ApoB

GUDID 00810040821028

Sample Collection Kit, Blood (Adx Single), Cardiac Risk Test

Cue Health Inc.

Capillary blood collection kit IVD Capillary blood collection kit IVD Capillary blood collection kit IVD Capillary blood collection kit IVD Capillary blood collection kit IVD Capillary blood collection kit IVD Capillary blood collection kit IVD Capillary blood collection kit IVD Capillary blood collection kit IVD Capillary blood collection kit IVD Capillary blood collection kit IVD Capillary blood collection kit IVD Capillary blood collection kit IVD Capillary blood collection kit IVD Capillary blood collection kit IVD Capillary blood collection kit IVD

Primary Device ID	00810040821028
NIH Device Record Key	3f718d34-d0d1-4883-8110-92844e2376c7
Commercial Distribution Status	In Commercial Distribution
Brand Name	Heart Disease Risk Test: Lipoprotein a + ApoB
Version Model Number	C2225
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 Identifiers

Device Issuing Agency	Device ID
GS1	00810040821028 [Primary]

FDA Product Code

PQD	Blood Specimen Collection Convenience Kit (Excludes Hiv)

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

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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