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Access Ostase QC

FDA UDIEUDAMED

Class I (US FDA UDI)

by Beckman Coulter, Inc.

Identity

Trade Name
Access Ostase QC FDA UDI
Generic Name
Bone alkaline phosphatase (BALP) IVD, kit, chemiluminescent immunoassay FDA UDI
Device Name
The Access Ostase QC is intended for monitoring system performance of the Access Ostase assay. FDA UDI
Model / Reference
B83877 FDA UDI
Description
The Access Ostase QC is intended for monitoring system performance of the Access Ostase assay. FDA UDI

Identifiers

Catalog Number
B83877 FDA UDI
Primary DI / UDI-DI
15099590677398 FDA UDI
FDA Product Code
JJX FDA UDI
GMDN Term
Bone alkaline phosphatase (BALP) IVD, kit, chemiluminescent immunoassay 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

Yes

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

Yes

FDA UDI

Category: Bone alkaline phosphatase (BALP) IVD, kit, chemiluminescent immunoassay

Access Ostase QC by Beckman Coulter, Inc. — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Bone alkaline phosphatase (BALP) IVD, kit, chemiluminescent immunoassay.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

IVDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Beckman Coulter, Inc.

Sources (2)

  • FDA UDI f35a9d94-5381-435a-94f9-2a06f4b3d243 34 fields · synced Jun 18, 2026
  • EUDAMED 1 fields · synced Jun 2, 2026