FDA.report

PARATHYROID HORMONE CONTROL - LEVEL 3 (PTH CONTROL 3)

Primary DI
05055273215342
Brand
PARATHYROID HORMONE CONTROL - LEVEL 3 (PTH CONTROL 3)
Company
RANDOX LABORATORIES LIMITED
Model
PTH10112
Published
2019-06-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)

Product Code Classifications

CodeDeviceSpecialtyClass
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)Clinical Chemistry1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05055273215342PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05055273215342050552732153425055273215342

GMDN Terms

TermDefinition
Parathyroid hormone (PTH) IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of parathyroid hormone (PTH) [intact, whole, or truncated fragments] in a clinical specimen.

Sterilization Methods

Method

Regulatory Flags

DUNS number
227530649
Device count
1
DM exempt
false
Premarket exempt
true
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

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05055273218985ConcizuTrace™ ELISACZM10591CZM105912025-05-30
05055273210101Liquid Immunoassay Control – Level 1 (IA CONTROL 1)LIA5142LIA51422025-03-24
05055273210118LIQUID IMMUNOASSAY CONTROL - LEVEL 2 (IA CONTROL 2)LIA5143LIA51432025-03-24
05055273210125LIQUID IMMUNOASSAY CONTROL - LEVEL 3 (IA CONTROL 3)LIA5144LIA51442025-03-24
05055273219814PTH CONTROL LEVEL 1 (PTH CONTROL 1)PTH10608PTH106082025-03-24
05055273219821PTH CONTROL LEVEL 2 (PTH CONTROL 2)PTH10609PTH106092025-03-24
05055273219838PTH CONTROL LEVEL 3 (PTH CONTROL 3)PTH10610PTH106102025-03-24
05055273219043LIQUID CARDIAC CONTROL 1CQ10534CQ105342025-03-21
05055273219050LIQUID CARDIAC CONTROL 2CQ10535CQ105352025-03-21
05055273219067LIQUID CARDIAC CONTROL 3CQ10536CQ105362025-03-21
05055273219128LIQUID CARDIAC CONTROL LEVEL 1 (LIQUID CARDIAC CONTROL 1)CQ10616CQ106162025-03-21
05055273219135LIQUID CARDIAC CONTROL LEVEL 2 (LIQUID CARDIAC CONTROL 2)CQ10617CQ106172025-03-21
05055273219142LIQUID CARDIAC CONTROL LEVEL 3 (LIQUID CARDIAC CONTROL 3)CQ10618CQ106182025-03-21
05055273219159Assayed Liquid Chemistry Control Level 1 (ASY LIQ CHEM CONTROL 1)LAL10565LAL105652025-03-21
05055273219166Assayed Liquid Chemistry Control Level 2 (ASY LIQ CHEM CONTROL 2)LAN105662025-03-21
05055273219173Assayed Liquid Chemistry Control Level 3 (ASY LIQ CHEM CONTROL 3)LAE10567LAE105672025-03-21
05055273219180Assayed Liquid Chemistry Control Level 1 (ASY LIQ CHEM CONTROL 1)LAL10625 LAL10625 2025-03-21
05055273219197Assayed Liquid Chemistry Control Level 2 (ASY LIQ CHEM CONTROL 2)LAN10626LAN106262025-03-21
05055273219203Assayed Liquid Chemistry Control Level 3 (ASY LIQ CHEM CONTROL 3)LAE10627LAE106272025-03-21
05055273220018PlaySafe™ SCK10690SCK106902024-10-01

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