Who else makes this device?

Name: INS-Irma
Brand: INS-Irma

Clinical Chemistry › Test SystemsRadioimmunoassay, Immunoreactive Insulin

INS-Irma

Catalogue number KIP1251/KIP1254, listed by Diasource Immunoassays, S.A., United States, under Radioimmunoassay, Immunoreactive Insulin. 4 manufacturers in China are registered for this product code.

Registry build 21.09.26

4manufacturers in China registered for this device type

1catalogue number

Who Else Makes It

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

Chinese manufacturers registered for FDA product code CFP
Manufacturer	City	Province	Registered as	Device types
Dirui Industrial Co., Ltd.	Changchun	Jilin	Contract manufacturer	84
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 INS-Irma
Listed by	Diasource Immunoassays, S.A., United States
FDA product code	CFP
Device type	Radioimmunoassay, Immunoreactive Insulin
Device class	Class 1
Regulation	21 CFR 862.1405
Premarket notification	Exempt
Record published	2020-01-15

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Label carries	lot or batch number
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for INS-Irma
Catalogue number	Size	Status
KIP1251/KIP1254		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Salimetrics	Salimetrics LLC.	2
Elecsys Insulin	Roche Diagnostics Gmbh	2
Insulin	DRG Instruments Gesellschaft mit beschränkter Haftung	2
Insulin Elisa	DRG Instruments Gesellschaft mit beschränkter Haftung	2
Immulite® 2000 Systems INS Insulin	Siemens Healthcare Diagnostics Products GmbH	2
Atellica IM IRI DIL	Siemens Healthcare Diagnostics Inc	2
Advia Centaur® IRI	Siemens Healthcare Diagnostics Inc	2
Anti-Insulin Elisa	DRG Instruments Gesellschaft mit beschränkter Haftung	2
Atellica IM IRI	Siemens Healthcare Diagnostics Inc	2
Architect	Abbott Medical	1
Insulin Elisa Kit (Dako)	Mercodia AB	1
Insulin AccuBind Elisa Test System – 96 Wells	Monobind, Inc.	1

Showing 12 of 48. All products under Radioimmunoassay, Immunoreactive Insulin

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.