Architect

Activated Aspartate Aminotransferase 2750 Tests

Registry build 21.09.26
2manufacturers in China registered for this device type
4catalogue numbers in this listing

Who Else Makes It

Concentrated in Jilin (1), Shandong (1).

Chinese manufacturers registered for FDA product code CIT
Manufacturer City Province Registered as Device types
Dirui Industrial Co., Ltd. Changchun Jilin Contract manufacturer 84
Biobase Biodustry(Shandong)Co., Ltd. Jinan Shandong Manufacturer 70

Record

Regulatory record for Architect
Listed by Abbott Ireland, Ireland
FDA product code CIT
Device type Nadh Oxidation/Nad Reduction, Ast/Sgot
Device class Class 2
Regulation 21 CFR 862.1100
Establishment Specification developer, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2022-05-24
Record revised 2024-02-02 (version 4)

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 Handling environment temperature up to 30 °C; Storage environment temperature 2 to 8 °C

Catalogue Numbers

Catalogue numbers for Architect
Catalogue number Size Status
08L9124 In distribution
04S9030 In distribution
04S9020 In distribution
08L9144 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Biobase Biobase Biodustry(Shandong)Co., Ltd. 19
AST Randox Laboratories Limited 10
JAS Diagnostics Drew Scientific, Ltd. 7
Synermed® Infrared Laboratory Systems LLC 7
Pointe Scientific, Inc. Horiba Instruments Incorporated 5
AU Beckman Coulter, Inc. 4
Synchron Beckman Coulter, Inc. 4
ACE Alfa Wassermann 4
Architect Abbott Medical 3
Alinity Abbott Ireland 3
Architect Abbott Laboratories 3
Aspartate aminotransferase acc to Ifcc withwithout pyridoxal phosphate activat Roche Diagnostics Gmbh 3

Showing 12 of 62. All products under Nadh Oxidation/Nad Reduction, Ast/Sgot

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

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

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