Alinity

Alinity i 25-OH Vitamin D Reagent Kit 1000 Tests

Registry build 21.09.26
1manufacturer
2catalogue numbers in this listing

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 Alinity
Listed by Abbott Ireland, Ireland
FDA product code MRG
Device type System, Test, Vitamin D
Device class Class 2
Regulation 21 CFR 862.1825
Establishment Specification developer, Repacker / relabeller, Manufacturer
Record published 2018-07-31
Record revised 2023-10-09 (version 3)

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 8 °C

Catalogue Numbers

Catalogue numbers for Alinity
Catalogue number Size Status
08P4532 In distribution
08P4522 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
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
Advia Centaur® VitD Siemens Healthcare Diagnostics Inc 1

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

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.

Where China Actually Supplies

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5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer