Who else makes this device?

Name: Alpco Insulin Elisa Jumbo
Brand: Alpco Insulin Elisa Jumbo

Clinical Chemistry › Test SystemsRadioimmunoassay, Immunoreactive Insulin

Alpco Insulin Elisa Jumbo

The ALPCO Insulin ELISA is designed for the quantitative determination of insulin in serum and plasma. For in vitro diagnostic use.

Registry build 21.09.26

4manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

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 Alpco Insulin Elisa Jumbo
Listed by	American Laboratory Products Company, United States
FDA product code	CFP
Device type	Radioimmunoassay, Immunoreactive Insulin
Device class	Class 1
Regulation	21 CFR 862.1405
Establishment	Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification	Exempt
Record published	2020-09-25

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
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 Alpco Insulin Elisa Jumbo
Catalogue number	Size	Status
80-INSHU-E10.1		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

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K963911	1996-11-01

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.