Max. value paid with public resources: Processing

Data for med. device

Medical device code

06DV0000010180

Form date

07/03/2020 09:19

Record date MD

09/03/2020 15:00

Date introduce requestor in the system

02/05/2018 11:02

Identification of the manufacturer

Manufacturer name, long

Acro Biotech Inc.

Code type

Other

Document type

00000

Code

00000

Country code

US

City	Rancho Cucamonga, CA

Contact person

Cheryl Zhu

Phone

+1 (909) 466-6892

E-mail

customerservice2@acrobiotech.com

Identification of the person placing the product on the market

Name of the person placing the product on the market

ABEL DEMEDICAL LTD

Code type

EIK

Code

204849693

Country code

BG

Region code

SOF

City

Sofia

Contact person

Elly Tchoubrieva

Phone

0884715946

E-mail

office@abeldemedical.com

Identification of the wholesaler

Wholesaler name

ABEL DEMEDICAL LTD

Code type

EIK

Code

204849693

Country code

BG

Region code

SOF

City

Sofia

Contact person

Elly Tchoubrieva

Phone

0884715946

E-mail

office@abeldemedical.com

Number of authorization/certificate for wholesale trade with medical devices

IV-P-T/ МИ1451

Date of authorization/certificate for wholesale trade with medical devices

14/12/2017

General medical information about the device

Category of the medical device

06 - In vitro diagnostic devices

Risk clasification

IVD others

Anatomical group

Various

Code type

GMDN

Code value

00000

Name	2019-nCOV IgGIgM Rapid Test Cassette Single use

Description of the medical device

Number in one package

1

Size	10 tests/pack

Intended action by the manufacturer

Purpose

The 2019-nCoV IgG/IgM Rapid Test Cassette is a lateral flow chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to 2019-nCoV in human Fingerstick Whole Blood specimen.

Storage conditions

15-30°C

Usage

Single use

Number in catalog

INCP-402S

General trade information

Max. value paid with public resources

Processing