Who else makes this device?

Name: Architect
Brand: Architect

Architect · Turbidimetric, Total Protein → Clinical Chemistry

1manufacturer

2catalogue numbers in this listing

2510(k) clearances naming this product code

Who Else Makes It

Registered in Jilin.

Chinese manufacturers registered for FDA product code JGQ
Manufacturer	City	Province	Registered as	Device types
Dirui Industrial Co., Ltd.	Changchun	Jilin	Contract manufacturer	84

Record

Regulatory record for Architect
Listed by	Abbott Laboratories, United States
FDA product code	JGQ
Device type	Turbidimetric, Total Protein
Device class	Class 2
Regulation	21 CFR 862.1635
Establishment	Specification developer, Complaint-file establishment, Manufacturer, Exporter
Record published	2016-09-09
Record revised	2018-03-29 (version 2)

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 29 °C; Storage environment temperature 15 to 30 °C

Catalogue Numbers

Catalogue numbers for Architect
Catalogue number	Size	Status
7D79-21		In distribution
7D79-31		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Total Protein UrineCSF Gen3	Roche Diagnostics Gmbh	2
Alinity	Abbott Medical	2
Architect	Abbott Medical	2
Total Protein Urine/CSF Gen.3	Roche Diagnostics Gmbh	1
Thermo Scientific Infinity™	Fisher Diagnostics	1
Protein Total Protein in UrineCerebrospinal Fluid	Roche Diagnostics Gmbh	1

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K981295	1998-10-01
K981682	1998-09-21

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.

Architect