FDA.reportPublic FDA data

Mission Plus Hemoglobin (Hb) Optical Verifier

Primary DI
20682607610567
Brand
Mission Plus Hemoglobin (Hb) Optical Verifier
Company
ACON LABORATORIES, INC.
Model
C122-3021
Device description
Box of 2 Optical Verifiers (1 vial)
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
GKRSYSTEM, HEMOGLOBIN, AUTOMATED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GKRSystem, Hemoglobin, AutomatedHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122553000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122553000MISSION PLUS HB HEMOGLOBIN TESTING SYSTEMACON Laboratories, Inc.2013-08-05GKR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20682607610567PackageGS1200In Commercial Distribution
00682607610563PrimaryGS10
00682607000241Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2068260761056720682607610567
00682607610563006826076105636826076105630682607610563
00682607000241006826070002416826070002410682607000241

GMDN Terms#

Term, Definition table
TermDefinition
Haemoglobin analyser IVD, point-of-careA mains electricity (AC-powered) instrument, which may include internal rechargeable batteries, intended to be used by health professionals at the point-of-care, and often also in the laboratory, to determine the concentration of haemoglobin in a clinical specimen, using technology which may include colorimetry, electrometry or photometry.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep out of direct sunlight
Special Storage Condition, Specify00Store in a cool, dry place
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)838-9502support@aconlabs.com

Regulatory Flags#

DUNS number
781100966
Device count
2
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00682607551354ON CALL® SURE BLOOD GLUCOSE STRIPSOGS-211G135-20U-1012026-07-31
00682607551361ON CALL® SURE BLOOD GLUCOSE STRIPSOGS-211G135-20U-1042026-07-31
00682607551378ON CALL® SURE BLOOD GLUCOSE STRIPSOGS-211G135-20U-1052026-07-31
00682607815234ON CALL® SURE BLOOD KETONE STRIPSOGS-511GK135-201-1012026-07-31
00682607815241ON CALL® SURE BLOOD KETONE STRIPSOGS-511GK135-201-1022026-07-31
00682607815258ON CALL® SURE BLOOD KETONE STRIPSOGS-511GK135-201-1042026-07-31
00682607815265ON CALL® SURE BLOOD KETONE STRIPSOGS-511GK135-201-1052026-07-31
00682607551385ON CALL® SURE BLOOD CONTROL SOLUTIONOGS-211G125-22U-1012026-07-30
00682607551392ON CALL® SURE BLOOD GLUCOSE MONITORING SYSTEMOGM-211G115-20U-1012026-07-30
00682607551408ON CALL® SURE BLOOD GLUCOSE METEROGM-211G115-21U-1012026-07-30
00682607551422ON CALL® SURE BLOOD GLUCOSE METEROGM-211G115-22U-1012026-07-30
00682607551439ON CALL® SURE BLOOD GLUCOSE METEROGM-211G115-23U-1012026-07-30
00682607551446ON CALL® SURE SYNC BLOOD GLUCOSE MONITORING SYSTEMOGM-212G115-20W-1012026-07-30
00682607551453ON CALL® SURE SYNC BLOOD GLUCOSE METEROGM-212G115-21W-1012026-07-30
00682607551460ON CALL® SURE SYNC BLOOD GLUCOSE METEROGM-212G115-22W-1012026-07-30
00682607551477ON CALL® SURE SYNC BLOOD GLUCOSE METEROGM-212G115-23W-1012026-07-30
00682607815098ON CALL® SURE GK BLOOD GLUCOSE & KETONE MONITORING SYSTEMOGM-511GK115-201-1012026-07-30
00682607815104ON CALL® SURE GK BLOOD GLUCOSE & KETONE METEROGM-511GK115-221-1012026-07-30
00682607815111ON CALL® SURE SYNC GK BLOOD GLUCOSE & KETONE MONITORING SYSTEMOGM-512GK115-222-1012026-07-30
00682607815272ON CALL® SURE KETONE CONTROL SOLUTIONOGC-511GK125-221-1012026-07-30

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