Architect

ARCHITECT Tacrolimus Whole Blood Precipitation Reagent

Registry build 21.09.26
1manufacturer
11catalogue numbers in this listing

Who Else Makes It

Registered in Jiangsu.

Chinese manufacturers registered for FDA product code JIT
Manufacturer City Province Registered as Device types
Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. Suzhou Jiangsu Contract manufacturer 4

Record

Regulatory record for Architect
Listed by Abbott Ireland Diagnostics
FDA product code JIT
Device type Calibrator, Secondary
Device class Class 2
Regulation 21 CFR 862.1150
Premarket notification Exempt
Record published 2016-06-06
Record revised 2025-01-23 (version 8)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Supplied as a kit Yes
Latex Contains natural rubber latex
Label carries lot or batch number, expiry date
Storage Storage environment temperature 15 to 30 °C

Catalogue Numbers

Catalogue numbers for Architect
Catalogue number Size Status
1L77-55 In distribution
2K47-10 In distribution
2K46-25 In distribution
1L76-25 In distribution
8D15-25 In distribution
1L76-01 In distribution
2K46-10 In distribution
1L76-55 In distribution
8D15-02 In distribution
04W1801 In distribution
04W1601 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Vitros Ortho-Clinical Diagnostics, Inc. 39
Exact Diagnostics Exact Diagnostics 30
Architect Abbott Medical 26
Architect Abbott Ireland 24
Alinity Abbott Medical 18
Alinity Abbott Ireland 16
Architect Abbott Laboratories 15
Alinity Abbott Ireland Diagnostics 11
JAS Diagnostics Drew Scientific, Ltd. 10
BioPlex 2200 Bio-Rad Laboratories Inc. 8
AU Beckman Coulter, Inc. 6
Fluid Pack Diamond Diagnostics Inc. 5

Showing 12 of 391. All products under Calibrator, Secondary

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