Who else makes this device?

Name: 1,25-Dihydroxy Vitamin D EIA
Brand: 1,25-Dihydroxy Vitamin D EIA

Clinical Chemistry › Test SystemsSystem, Test, Vitamin D

1,25-Dihydroxy Vitamin D EIA

Catalogue number AC-62F1, listed by Immunodiagnostic Systems Ltd., United Kingdom, under System, Test, Vitamin D. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

1manufacturer

1catalogue number

9510(k) clearances naming this product code

Who Else Makes It

Registered in Guangdong.

Chinese manufacturers registered for FDA product code MRG
Manufacturer	City	Province	Registered as	Device types
Shenzhen NEW Industries Biomedical Engineering Co., Ltd.	Shenzhen	Guangdong	Manufacturer	4

Record

Regulatory record for 1,25-Dihydroxy Vitamin D EIA
Listed by	Immunodiagnostic Systems Ltd., United Kingdom
FDA product code	MRG
Device type	System, Test, Vitamin D
Device class	Class 2
Regulation	21 CFR 862.1825
Establishment	Contract manufacturer, Manufacturer
510(k)	K051110
Record published	2016-04-01
Record revised	2018-07-06 (version 3)

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	Special storage condition: Store upon receipt at 2 to 8 degrees celsius; Storage environment temperature 2 to 8 °C; Handling environment temperature 2 to 8 °C

Catalogue Numbers

Catalogue numbers for 1,25-Dihydroxy Vitamin D EIA
Catalogue number	Size	Status
AC-62F1		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
BioPlex 2200	Bio-Rad Laboratories Inc.	6
Access 25(OH) Vitamin D Total	Beckman Coulter, Inc.	3
Maglumi 25-OH Vitamin D	Shenzhen NEW Industries Biomedical Engineering Co., Ltd.	3
Architect	Abbott Medical	3
Atellica™ IM VitD	Siemens Healthcare Diagnostics Inc	2
1,25 Dihydroxy Vitamin D RIA	Immunodiagnostic Systems Ltd.	2
Maglumi 2000 25-OH Vitamin D	Shenzhen NEW Industries Biomedical Engineering Co., Ltd.	2
Alinity	Abbott Ireland	2
Architect	Abbott Ireland	2
Elecsys Vitamin D total II	Roche Diagnostics Gmbh	2
IDS-iSYS 25 VitDS	Immunodiagnostic Systems Ltd.	2
Elecsys Vitamin D total III	Roche Diagnostics Gmbh	2

Showing 12 of 50. All products under System, Test, Vitamin D

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K161831	2016-11-15
K142351	2015-08-25
K140554	2014-12-19
K123253	2013-06-18
K091849	2010-06-25
K051110	2005-07-06
K042519	2004-12-01
K021163	2002-05-10
K991998	1999-09-17

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.