CRYOcheck Hex LA HEXLA-M

GUDID 00843876000596

CRYOcheck Hex LA is for clinical laboratory use as a qualitative test kit intended to aid in the detection of lupus anticoagulants (LA) in 3.2% citrated human plasma by the application of hexagonal phase phospholipids. CRYOcheck Hex LA should be used as an integrated test for lupus anticoagulant detection. For in vitro diagnostic use. The performance of this device has not been established in neonate and pediatric patient populations.

Precision Biologic Inc

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• Primary Device ID: 00843876000596
• NIH Device Record Key: d5ee151b-9c8a-48d8-9c15-1ac5333b8556
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CRYOcheck Hex LA
• Version Model Number: HEXLA-M
• Catalog Number: HEXLA-M
• Company DUNS: 244713368
• Company Name: Precision Biologic Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and -70 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -70 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -70 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -70 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -70 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -70 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -70 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -70 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -70 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -70 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -70 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -70 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -70 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -70 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -70 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -70 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00843876000596 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193556

FDA Product Code

• GFO: Activated Partial Thromboplastin

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-10
• Device Publish Date: 2023-05-02

Devices Manufactured by Precision Biologic Inc

• 00843876010557 - CRYOcheck Factor VIII Deficient Plasma with VWF: 2023-10-03 CRYOcheck Factor VIII Deficient Plasma with VWF is for clinical laboratory use as a deficient substrate in the quantitative dete
• 00843876010564 - CRYOcheck Factor VIII Deficient Plasma with VWF: 2023-10-03 CRYOcheck Factor VIII Deficient Plasma with VWF is for clinical laboratory use as a deficient substrate in the quantitative dete
• 00843876000596 - CRYOcheck Hex LA: 2023-05-10CRYOcheck Hex LA is for clinical laboratory use as a qualitative test kit intended to aid in the detection of lupus anticoagulants (LA) in 3.2% citrated human plasma by the application of hexagonal phase phospholipids. CRYOcheck Hex LA should be used as an integrated test for lupus anticoagulant detection. For in vitro diagnostic use. The performance of this device has not been established in neonate and pediatric patient populations.
• 00843876000596 - CRYOcheck Hex LA: 2023-05-10 CRYOcheck Hex LA is for clinical laboratory use as a qualitative test kit intended to aid in the detection of lupus anticoagulan
• 00843876000558 - CRYOcheck Factor VIII Chromogenic: 2020-08-04 CRYOcheck Chromogenic Factor VIII is for clinical laboratory use in the quantitative determination of factor VIII activity in 3.
• 00843876000534 - CRYOcheck Lupus Negative Control: 2020-03-16 Prepared from human source plasma and recommended as a negative control in assays for lupus anticoagulant.
• 00843876000541 - CRYOcheck Lupus Negative Control: 2020-03-16 Prepared from human source plasma and recommended as a negative control in assays for lupus anticoagulant.
• 00843876000503 - CRYOcheck™ FVIII Inhibitor Kit: 2019-04-02 The CRYOcheck FVIII Inhibitor Kit is for clinical laboratory use in conjunction with a factor VIII activity assay to enable perf
• 00843876000015 - CRYOcheck™ Pooled Normal Plasma: 2018-07-06