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Cal-Chex A Plus

FDA UDI

Class II (US FDA UDI)

by Streck

Identity

Trade Name
Cal-Chex A Plus FDA UDI
Generic Name
Full blood count IVD, calibrator FDA UDI
Device Name
A hematology calibrator assayed for the Abbott CELL-DYN® 3200, 3500, 3700 and Ruby® analyzers. Contains 2 vials. FDA UDI
Model / Reference
221107 FDA UDI
Description
A hematology calibrator assayed for the Abbott CELL-DYN® 3200, 3500, 3700 and Ruby® analyzers. Contains 2 vials. FDA UDI

Identifiers

Catalog Number
221107 FDA UDI
Primary DI / UDI-DI
30844509000311 FDA UDI
510(k) Number
K020469 FDA UDI
FDA Product Code
KSA FDA UDI
KRY FDA UDI
KRX FDA UDI
KRZ FDA UDI
GMDN Term
Full blood count IVD, calibrator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.8185 FDA UDI
864.8175 FDA UDI
864.8150 FDA UDI
864.8165 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 — 3.0 Milliliter FDA UDI

Category: Full blood count IVD, calibrator

Cal-Chex A Plus by Streck — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Full blood count IVD, calibrator.

Cleared under the same submission

K020469 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 c7a8129d-4f34-47c2-841c-a231893a134b 38 fields · synced May 30, 2026