Who else makes this device?

Name: Serodia TP-PA
Brand: Serodia TP-PA

Serodia TP-PA · Antigens, Ha, Treponema Pallidum → Immunology & Microbiology

1manufacturer

2catalogue numbers in this listing

1510(k) clearance

Who Else Makes It

Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code GMT
Manufacturer	City	Province	Registered as	Device types
Zhuhai Livzon Diagnostics Inc.	Zhuhai	Guangdong	Contract manufacturer	3

Record

Regulatory record for Serodia TP-PA
Listed by	Fujirebio Diagnostics, AB, Sweden
FDA product code	GMT
Device type	Antigens, Ha, Treponema Pallidum
Device class	Class 2
Regulation	21 CFR 866.3830
Establishment	Contract manufacturer, Manufacturer, Exporter
510(k)	K971502
Record published	2016-09-16
Record revised	2020-07-15 (version 4)

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 10 °C; Handling environment temperature 2 to 30 °C

Catalogue Numbers

Catalogue numbers for Serodia TP-PA
Catalogue number	Size	Status
1633	Size Type = Tests per Kit; Size Unit = 220; Unit of Measure = Tests	In distribution
1626	Size Type = Tests per Kit; Size Unit = 100; Unit of Measure = Tests	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Serodia TP-PA Kits	Fujirebio Diagnostics, AB	2

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K893124	1989-11-17

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.

Serodia TP-PA