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HQ-Chex

FDA UDI

Class I (US FDA UDI)

by Streck

Identity

Trade Name
HQ-Chex FDA UDI
Generic Name
Glucose/haemoglobin (Hb) IVD, control FDA UDI
Device Name
A whole blood glucose and hemoglobin control designed to evaluate the accuracy and precision of HemoCue® analyzers. Contains 6 vials of level 3. FDA UDI
Model / Reference
232755 FDA UDI
Description
A whole blood glucose and hemoglobin control designed to evaluate the accuracy and precision of HemoCue® analyzers. Contains 6 vials of level 3. FDA UDI

Identifiers

Catalog Number
232755 FDA UDI
Primary DI / UDI-DI
20844509001694 FDA UDI
510(k) Number
K933844 FDA UDI
FDA Product Code
JJY FDA UDI
GMDN Term
Glucose/haemoglobin (Hb) IVD, control FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1660 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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

Dimensions & Sizes

Size
Total Volume — 2.5 Milliliter FDA UDI

Category: Glucose/haemoglobin (Hb) IVD, control

HQ-Chex by Streck — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Glucose/haemoglobin (Hb) IVD, control.

Cleared under the same submission

K933844 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Streck

Sources (1)

  • FDA UDI 2497e641-bd0b-4e53-80d9-11773e3a8fb9 38 fields · synced May 30, 2026