Who else makes this device?

Name: Access Total BhCG (5th IS)
Brand: Access Total BhCG (5th IS)

Clinical Chemistry › Test SystemsSystem, Test, Human Chorionic Gonadotropin

Access Total BhCG (5th IS)

The Access Total BhCG (5th IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total BhCG levels in human serum and plasma using the…

Registry build 21.09.26

The Access Total BhCG (5th IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total BhCG levels in human serum and plasma using the Access Immunoassay Systems. This assay is intended for use as an aid in the early detection of pregnancy.

3manufacturers in China registered for this device type

2catalogue numbers in this listing

2510(k) clearances naming this product code

Who Else Makes It

Concentrated in Guangdong (2), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code DHA
Manufacturer	City	Province	Registered as	Device types
Hangzhou Biotest Biotech Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	41
Guangzhou Wondfo Biotech Co., Ltd.	Guangzhou	Guangdong	Contract manufacturer	44
Shenzhen Yhlo Biotech Co., Ltd.	Shenzhen	Guangdong	Manufacturer	19

Record

Regulatory record for Access Total BhCG (5th IS)
Listed by	Beckman Coulter, Inc., United States
FDA product code	DHA
Device type	System, Test, Human Chorionic Gonadotropin
Device class	Class 2
Regulation	21 CFR 862.1155
Establishment	Contract manufacturer, Specification developer, Manufacturer, Exporter
Record published	2016-09-09
Record revised	2018-04-09 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date, manufacturing date

Catalogue Numbers

Catalogue numbers for Access Total BhCG (5th IS)
Catalogue number	Size	Status
A85264		In distribution
C28645		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
BioSign® hCG card	Princeton BioMeditech Corp.	5
Architect	Abbott Ireland	5
BioStrip® P	Princeton BioMeditech Corp.	4
AccuHome Pregnancy Test	Germaine Laboratories, Inc.	3
Elecsys HCG Test System	Roche Diagnostics Gmbh	3
Status hCG card	Princeton BioMeditech Corp.	3
Vitros	Ortho-Clinical Diagnostics, Inc.	2
Maglumi 2000 HCG/beta-HCG	Shenzhen NEW Industries Biomedical Engineering Co., Ltd.	2
Immulite®/Immulite® 1000 Systems HCG Sample Diluent	Siemens Healthcare Diagnostics Products GmbH	2
Alinity	Abbott Ireland	2
Immulite® 2000 Systems HCG	Siemens Healthcare Diagnostics Products GmbH	2
McKesson	Mckesson Medical-Surgical Inc.	2

Showing 12 of 46. All products under System, Test, Human Chorionic Gonadotropin

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K221990	2022-12-27
K130020	2013-10-01

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.