iHealth

GUDID 10850044118424

IHEALTH LAB INC.

SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing

• Primary Device ID: 10850044118424
• NIH Device Record Key: c28143d1-b323-4776-bf05-5d031bd8cdd2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iHealth
• Version Model Number: ICF-3000
• Company DUNS: 054953337
• Company Name: IHEALTH LAB 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850044118427 [Primary]
GS1	10850044118424 [Package]; Contains: 00850044118427; Package: [1 Units]; In Commercial Distribution
GS1	20850044118421 [Package]; Package: [1 Units]; In Commercial Distribution
GS1	30850044118428 [Package]; Contains: 20850044118421; Package: [48 Units]; In Commercial Distribution

FDA Product Code

• QKP: Coronavirus Antigen Detection Test System.

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: 2024-06-03
• Device Publish Date: 2024-05-25

On-Brand Devices [iHealth]

• 00856362005258: TS28B
• 20856362005191: EGS-2003
• 10856362005019: ECG3
• 10855111003047: BP5
• 10856362005132: HS2S
• 10856362005040: PT3
• 00856362005609: PT2L
• 10856362005811: PT1
• 00850044118021: BP5S
• 10856362005996: PT5
• 10850044118004: KD-723
• 10856362005101: BP3L
• 10856362005095: BP3L
• 10856362005002: KN-550BT
• 10855111003955: BP3L
• 10850044118066: ICO-3000
• 10850044118059: ICO-3000
• 10850044118042: ICO-3000
• 10850044118035: HS2S Pro
• 10856362005057: BPM1
• 10855111003917: PO3M
• 10855111003276: PO3
• 00850044118083: PT3
• 10850044118202: EGS-2003
• 10850044118264: EGS-2003
• 10850044118257: EGS-2003
• 10850044118455: ICF-3000
• 10850044118431: ICF-3000
• 10850044118424: ICF-3000
• 10850044118240: BG5SKIT
• 10850044118233: BG5SKIT
• 10850044118783: F5043
• 10850044118868: ANC1