Who else makes this device?

Name: Cal Dye Reference Standard
Brand: Cal Dye Reference Standard

Hematology › Automated Hematology DevicesSystem, Hemoglobin, Automated

Cal Dye Reference Standard

Catalogue number 00003315050, listed by Instrumentation Laboratory SPA, Italy, under System, Hemoglobin, Automated. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

1manufacturer

1catalogue number

1510(k) clearance

Who Else Makes It

Registered in Zhejiang. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code GKR
Manufacturer	City	Province	Registered as	Device types
Acon Biotech (Hangzhou) Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	29

Record

Regulatory record for Cal Dye Reference Standard
Listed by	Instrumentation Laboratory SPA, Italy
FDA product code	GKR
Device type	System, Hemoglobin, Automated
Device class	Class 2
Regulation	21 CFR 864.5620
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Record published	2016-09-23
Record revised	2021-07-08 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature 15 to 25 °C; Special storage condition: CalDye Reference Standard is stable until the expiration date shown on the product labeling if stored at room temperatur
Distribution end date	2018-03-09

Catalogue Numbers

Catalogue numbers for Cal Dye Reference Standard
Catalogue number	Size	Per pack	Status
00003315050		50	Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
RAPIDPoint® 405/500 Measurement Cartridge	Siemens Healthcare Diagnostics Inc	8
McKesson	Mckesson Medical-Surgical Inc.	6
HemoCue® Hb 301 Microcuvettes	Hemocue AB	5
HemoCue® Hb 201 Microcuvettes	Hemocue AB	4
Henry Schein	Henry Schein, Inc.	4
Mission Plus Hemoglobin (Hb) Monitoring System	Acon Laboratories, Inc.	3
Mission Plus Hemoglobin (Hb) Test Cartridges	Acon Laboratories, Inc.	3
DiaSpect Tm	EKF Diagnostic Gmbh	2
HemoCue® Hb 201+ Analyzer	Hemocue AB	2
Mission Capillary Transfer Tubes	Acon Laboratories, Inc.	2
Mission Plus Hemoglobin (Hb) Optical Verifier	Acon Laboratories, Inc.	2
HemoCue® Hb301 Analyzer	Hemocue AB	2

Showing 12 of 43. All products under System, Hemoglobin, Automated

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K945677	1995-10-20

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.