Who else makes this device?

Name: Vidas® Progesterone
Brand: Vidas® Progesterone

Clinical Chemistry › Test SystemsRadioimmunoassay, Progesterone

Vidas® Progesterone

VIDAS ® Progesterone (PRG) assay is a quantitative IA intended for use on VIDAS family instrument in the determination of progesterone concentration in human serum or plasma.

Registry build 21.09.26

4manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

2recalls on this code

Who Else Makes It

Concentrated in Hebei (1), Guangdong (1), Jiangsu (1).

Chinese manufacturers registered for FDA product code JLS
Manufacturer	City	Province	Registered as	Device types
Shijiazhuang Hipro Biotechnology Co., Ltd.	Shijiazhuang	Hebei	Manufacturer	22
Shenzhen Yhlo Biotech Co., Ltd.	Shenzhen	Guangdong	Manufacturer	19
Getein Biotech, Inc.	Nanjing	Jiangsu	Manufacturer	19
Beijing Hotgen Biotech Co., Ltd.	Beijing	Beijing	Manufacturer	13

Record

Regulatory record for Vidas® Progesterone
Listed by	bioMerieux, Inc., United States
FDA product code	JLS
Device type	Radioimmunoassay, Progesterone
Device class	Class 1
Regulation	21 CFR 862.1620
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
510(k)	K965084
Record published	2019-07-26

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
Storage	Storage environment temperature 2 to 8 °C

Catalogue Numbers

Catalogue numbers for Vidas® Progesterone
Catalogue number	Size	Status
30409-01		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
MP Biomedicals LLC	Mp Biomedicals, LLC	4
Elecsys Progesterone III	Roche Diagnostics Gmbh	3
Alinity	Abbott Ireland	3
Architect	Abbott Ireland	3
Salimetrics	Salimetrics LLC.	3
Atellica IM Prge	Siemens Healthcare Diagnostics Inc	3
Salivary Progesterone Elisa	DRG Instruments Gesellschaft mit beschränkter Haftung	2
Vitros	Ortho-Clinical Diagnostics, Inc.	2
Immulite®/Immulite® 1000 Systems PRG Progesterone	Siemens Healthcare Diagnostics Products GmbH	2
Salivary Progesterone HS Elisa	DRG Instruments Gesellschaft mit beschränkter Haftung	2
Progesterone Luminescence Immunoassay	IBL International Gmbh	2
Progesterone Elisa	DRG Instruments Gesellschaft mit beschränkter Haftung	2

Showing 12 of 54. All products under Radioimmunoassay, Progesterone

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K965084	1997-01-09

Recalls Naming This Product

1 recall names this product by its own identifier, the UDI on its label.

Recalls naming the identifiers of Vidas® Progesterone
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
bioMerieux, Inc.	UDI-DI	2022-11-09	Class II	Storage	As the temperature and time out of range was exceeded, product performances cannot be guaranteed	6 units

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity
2021-09-22	Class II	Nonconforming Material/Component	bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.	1818 units

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.