← Back to catalogue

ClearChem Diagnostics Inc. Alkaline Phosphatase (ALP)

FDA UDI

Class II (US FDA UDI)

by Clearchem Diagnostics Inc.

Identity

Trade Name
ClearChem Diagnostics Inc. Alkaline Phosphatase (ALP) FDA UDI
Generic Name
Alkaline phosphatase (ALP) isoenzyme IVD, reagent FDA UDI
Device Name
In Vitro Diagnostics testing kit R1:3X48mL, R2:3X12mL FDA UDI
Model / Reference
ALP1010 FDA UDI
Description
In Vitro Diagnostics testing kit R1:3X48mL, R2:3X12mL FDA UDI

Identifiers

Catalog Number
ALP1010 FDA UDI
Primary DI / UDI-DI
00852169008027 FDA UDI
FDA Product Code
CJE FDA UDI
GMDN Term
Alkaline phosphatase (ALP) isoenzyme IVD, reagent FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1050 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

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 — 180 Milliliter FDA UDI

Category: Alkaline phosphatase (ALP) isoenzyme IVD, reagent

ClearChem Diagnostics Inc. Alkaline Phosphatase (ALP) by Clearchem Diagnostics Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Alkaline phosphatase (ALP) isoenzyme IVD, reagent.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Clearchem Diagnostics Inc.

Sources (1)

  • FDA UDI 884b337c-2923-4780-86c1-05c561298eb1 37 fields · synced Jun 8, 2026