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Tinaquant Cardiac Creactive Protein Latex High Sensitive

FDA UDI

Class II (US FDA UDI)

by Roche Diagnostics Corp.

Identity

Trade Name
Tinaquant Cardiac Creactive Protein Latex High Sensitive FDA UDI
Generic Name
C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry FDA UDI
Model / Reference
11972855216 FDA UDI

Identifiers

Catalog Number
11972855216 FDA UDI
Primary DI / UDI-DI
04015630912209 FDA UDI
510(k) Number
K042485 FDA UDI
FDA Product Code
NQD FDA UDI
GMDN Term
C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5270 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry

Tinaquant Cardiac Creactive Protein Latex High Sensitive by Roche Diagnostics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Roche Diagnostics Corp.

Sources (1)

  • FDA UDI bd200bbb-cfd9-4b81-aeb1-fea43d5d5620 35 fields · synced Jun 7, 2026