Diazyme Procalcitonin Control Set

Primary DI
00817089020924
Brand
Diazyme Procalcitonin Control Set
Company
DIAZYME LABORATORIES, INC.
Model
DZ558A-CON
Published
2017-09-05
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817089020924PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817089020924008170890209248170890209240817089020924

GMDN Terms#

Term, Definition table
TermDefinition
Procalcitonin (PCT) IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative measurement of procalcitonin (PCT) in a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080507219
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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
00817089022478DiazymeDZ248A-CON2026-01-21
00817089023048DiazymeDZ122A-KY12026-01-21
00817089023222Diazyme100148B-CAL2026-01-21
00817089023239Diazyme100148B-CON2026-01-21
00817089021556DiazymeDZ042A-C1V2023-11-29
00817089021617DiazymeDZ100148-CON2023-11-29
00817089021662DiazymeDZ131B-K2023-11-29
00817089022539DiazymeDZ152A-CON2023-11-29
00817089022584DiazymeDZ152A-CAL2023-11-29
00817089022744DiazymeDZ152A-KY12023-11-29
00817089023154DiazymeDZ153A-CON2023-11-29
00817089023161DiazymeDZ153A-CAL2023-11-29
00817089023352DiazymeDZ888A-K012023-11-29
00817089020825Adenosine Deaminase Assay KitDZ117A-K2023-10-26
00817089020832DiazymeDZ117A-CAL2020-07-29
00817089020849DiazymeDZ117A-CON2020-07-29
00817089022447DiazymeDZ062A-K2020-07-29
00817089022690DiazymeDZ558A-KY12020-07-29
00817089022751DiazymeDZ062A-CON2020-07-29
00817089022805DiazymeDZ168A-LIN2020-07-29