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Access Ostase Calibrators

FDA UDI

Class II (US FDA UDI)

by Beckman Coulter, Inc.

Identity

Trade Name
Access Ostase Calibrators FDA UDI
Generic Name
Bone alkaline phosphatase (BALP) IVD, kit, chemiluminescent immunoassay FDA UDI
Device Name
The Access Ostase Calibrators are intended to calibrate the Access Ostase assay for the quantitative determination of bone alkaline phosphatase (BAP) levels in human serum and plasma using the Access Immunoassay Systems. FDA UDI
Model / Reference
B83876 FDA UDI
Description
The Access Ostase Calibrators are intended to calibrate the Access Ostase assay for the quantitative determination of bone alkaline phosphatase (BAP) levels in human serum and plasma using the Access Immunoassay Systems. FDA UDI

Identifiers

Catalog Number
B83876 FDA UDI
Primary DI / UDI-DI
15099590677381 FDA UDI
510(k) Number
K994278 FDA UDI
FDA Product Code
JIS FDA UDI
GMDN Term
Bone alkaline phosphatase (BALP) IVD, kit, chemiluminescent immunoassay FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1150 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 Calibrators by Beckman Coulter, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Beckman Coulter, Inc.

Sources (1)

  • FDA UDI ba0c70af-28b5-4b65-94b1-16760fd6e86c 35 fields · synced Jun 8, 2026